<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/NCT01728454</url>
  </required_header>
  <id_info>
    <org_study_id>ZPE-202</org_study_id>
    <nct_id>NCT01728454</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis</brief_title>
  <official_title>A Phase 2, Multi-Center, Three-Arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Repros Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Repros Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine the safety and efficacy of two oral doses&#xD;
      of telapristone acetate administered to premenopausal women with pelvic pain associated with&#xD;
      endometriosis confirmed within the last seven years and using prescription analgesics for&#xD;
      symptomatic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a phase 2, 3-arm-study with an 18-week active dosing period and an option for&#xD;
      participants to receive 2 additional 16-week cycles of active treatment at their randomized&#xD;
      dose [6 mg or 12 mg/day]. Placebo participants who elect additional treatment will receive&#xD;
      treatment at 12 mg/day. The treatment dose will remain double-blind. The study will be&#xD;
      conducted in 3 stages. The first stage is a no treatment baseline assessment period. This&#xD;
      stage will last as long as it takes to record at least one full menstrual cycle (ovulation&#xD;
      until ovulation).&#xD;
&#xD;
      For stage 2, following the run-in stage, at Visit 3, 60 participants will be randomized into&#xD;
      one of 3 arms in a 1-1-1 fashion. The start of dosing should commence as soon as possible&#xD;
      after ovulation following the end of the previous menstrual event.&#xD;
&#xD;
      For stage 3, participants who are eligible to receive additional cycles of treatment and who&#xD;
      elect to continue treatment will be scheduled within a week before the second expected menses&#xD;
      (+/- 2 days), following the off-drug interval. Participants will receive 2 cycles of&#xD;
      treatment separated by an off-drug interval (ODI), after which they will be followed until&#xD;
      menses has returned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2013</start_date>
  <completion_date type="Actual">March 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 15, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
    <description>The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Individual BBSS Score for Dyspareunia</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
    <description>The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
    <description>The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Prescription Analgesics Usage</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
    <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Prescription Analgesics Usage</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
    <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Non-Prescription Analgesics Usage</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
    <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Non-Prescription Analgesics Usage</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
    <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Analgesics Usage</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
    <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Total Analgesics Usage</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
    <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in BBSS Physician-Reported Scores</measure>
    <time_frame>Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
    <description>BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score</measure>
    <time_frame>Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
    <description>A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS)</measure>
    <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
    <description>NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents &quot;no pain&quot; and 10 represents &quot;the worst pain possible&quot;. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 milligrams (mg)/day separated by an off-drug interval (ODI) in Stage 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telapristone acetate 6 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telapristone acetate 12 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching capsules, orally, once daily for 18 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telapristone acetate</intervention_name>
    <description>Telapristone acetate capsules, orally once daily for 18 weeks.</description>
    <arm_group_label>Telapristone acetate 12 mg</arm_group_label>
    <arm_group_label>Telapristone acetate 6 mg</arm_group_label>
    <other_name>Proellex®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult females between 18 and 47 years of age using prescription analgesics for&#xD;
             endometriosis pain and with a Biberoglu Behrman Symptom Severity Scale (BBSS) score ≥7&#xD;
             at screening (assessed over the previous 28 days).&#xD;
&#xD;
          -  Endometriosis diagnosis must have been surgically confirmed within 7 years. A&#xD;
             laparoscopic diagnosis is acceptable.&#xD;
&#xD;
          -  Participants must have a history of at least 3 regular menstrual cycles in which&#xD;
             symptoms of endometriosis occurred immediately prior to screening.&#xD;
&#xD;
          -  Normal or abnormal but non-clinically significant transvaginal ultrasound.&#xD;
&#xD;
          -  History of menstrual events occurring in regular cycles.&#xD;
&#xD;
          -  Agreement not to attempt to become pregnant during the trial.&#xD;
&#xD;
          -  Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid&#xD;
             alcohol consumption within 48 hours before each visit.&#xD;
&#xD;
          -  Ability to complete a daily electronic participant diary and study procedures in&#xD;
             compliance with the protocol.&#xD;
&#xD;
          -  Women of child-bearing potential must be willing to use double-barrier contraception&#xD;
             during the study and for 30 days after discontinuation of study medication. Acceptable&#xD;
             double-barrier methods are: male condom with spermicide; male condom with diaphragm;&#xD;
             diaphragm containing spermicide plus additional intra-vaginal spermicide.&#xD;
&#xD;
          -  Has a negative pregnancy test at the Screening and Baseline visits, and subsequent&#xD;
             study visits.&#xD;
&#xD;
          -  A Body Mass Index (BMI) between 18 and 39 inclusive.&#xD;
&#xD;
          -  Is available for all treatment and follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post-menopausal woman, defined as either; six (6) months or more (immediately prior to&#xD;
             screening visit) without a menstrual period, or prior hysterectomy and/or&#xD;
             oophorectomy.&#xD;
&#xD;
          -  Pregnant or lactating or is attempting or expecting to become pregnant during the 6-7&#xD;
             month study period.&#xD;
&#xD;
          -  Women with abnormally high liver enzymes or liver disease [alanine transaminase (ALT)&#xD;
             or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and&#xD;
             total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat].&#xD;
&#xD;
          -  Received an investigational drug in the 30 days prior to the screening for this study.&#xD;
&#xD;
          -  History of polycystic ovary syndrome (PCOS).&#xD;
&#xD;
          -  Concurrent use of any testosterone, androgen, anabolic steroids,&#xD;
             dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to&#xD;
             screening and during the study. Oral contraceptive use for control of endometriosis&#xD;
             symptoms is acceptable for the first 28-days of the study.&#xD;
&#xD;
          -  Use of Depo-Provera® in the preceding 6 months.&#xD;
&#xD;
          -  Use of Gonadotrophin releasing hormone (GnRH) as (e.g. Lupron Depot) within 3 months&#xD;
             of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months&#xD;
             after the period of duration of the Lupron dose).&#xD;
&#xD;
          -  Has an intrauterine device (IUD) in place. Copper IUDs (non-hormone containing will be&#xD;
             permitted).&#xD;
&#xD;
          -  Presence of intramural fibroids that impact the endometrial stripe, submucosal&#xD;
             fibroids (any size), or endometrial polyps. Subserosal and intramural fibroids with no&#xD;
             impact on the endometrial stripe are acceptable.&#xD;
&#xD;
          -  Presence of endometrioma(s).&#xD;
&#xD;
          -  Present history or condition that causes non-endometriosis related dyspareunia (e.g.&#xD;
             vulvar vestibulitis).&#xD;
&#xD;
          -  Past or present history of thrombophlebitis or thromboembolic disorders.&#xD;
&#xD;
          -  Known or suspected carcinoma of the breast or reproductive organs.&#xD;
&#xD;
          -  History of abnormal electrocardiogram (ECG) that, in the opinion of the investigator,&#xD;
             is clinically significant and will prevent the participant from completing the study,&#xD;
             including a QTc (corrected QT interval) of greater than 450 milliseconds (ms).&#xD;
&#xD;
          -  Cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance&#xD;
             (ASCUS) associated with high-risk human papilloma virus (HPV) or Low/High Grade&#xD;
             Squamous Intraepithelial Lesion (LGSIL or HGSIL).&#xD;
&#xD;
          -  History of abnormal endometrial biopsy including the presence of Endometrial&#xD;
             Intraepithelial Neoplasia (EIN).&#xD;
&#xD;
          -  Recent history (within past 6 months) of alcoholism or drug abuse.&#xD;
&#xD;
          -  Known active infection with Human Immunodeficiency Virus (HIV), Hepatitis A, B or C.&#xD;
&#xD;
          -  Previous history of auto-immune disease and/or positive antinuclear antigen (ANA).&#xD;
&#xD;
          -  Endometrial stripe ≥18 mm in thickness at Visit 1.&#xD;
&#xD;
          -  Women currently taking cimetidine or spironolactone.&#xD;
&#xD;
          -  Clinically significant abnormal findings on screening examination and laboratory&#xD;
             assessments or any condition which in the opinion of the investigator would interfere&#xD;
             with the participant's ability to comply with the study instructions or endanger the&#xD;
             participant if she took part in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>47 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Chan</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Margate</city>
        <state>Florida</state>
        <zip>33063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riverton</city>
        <state>Utah</state>
        <zip>84065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://reprosrx.com</url>
    <description>Sponsor corporate web page</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <results_first_submitted>May 23, 2019</results_first_submitted>
  <results_first_submitted_qc>July 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2019</results_first_posted>
  <disposition_first_submitted>July 26, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>July 26, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 31, 2018</disposition_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT01728454/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT01728454/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 milligrams (mg)/day separated by an off-drug interval (ODI) in Stage 3.</description>
        </group>
        <group group_id="P2">
          <title>Telapristone Acetate 6 mg</title>
          <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
        </group>
        <group group_id="P3">
          <title>Telapristone Acetate 12 mg</title>
          <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Stage 1 and 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved to Active Drug/ Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew due to Adverse Events/Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Stage 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6">Eligible participants who opted to participate in Stage 3.</participants>
                <participants group_id="P2" count="5">Eligible participants who opted to participate in Stage 3.</participants>
                <participants group_id="P3" count="11">Eligible participants who opted to participate in Stage 3.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Reason Missing</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Required Other Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </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="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew due to Adverse Events/Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all study participants who were randomized, received study drug, and had some post-baseline safety data.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
        </group>
        <group group_id="B2">
          <title>Telapristone Acetate 6 mg</title>
          <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
        </group>
        <group group_id="B3">
          <title>Telapristone Acetate 12 mg</title>
          <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
        </group>
        <group group_id="B4">
          <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="20"/>
            <count group_id="B3" value="23"/>
            <count group_id="B4" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.3" spread="6.52"/>
                    <measurement group_id="B2" value="30.8" spread="5.93"/>
                    <measurement group_id="B3" value="30.1" spread="7.07"/>
                    <measurement group_id="B4" value="29.8" spread="6.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic or Non-Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea</title>
        <description>The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
        <population>Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea</title>
          <description>The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
          <population>Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.</population>
          <units>score on a scale per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="5.58"/>
                    <measurement group_id="O2" value="10.8" spread="6.90"/>
                    <measurement group_id="O3" value="11.1" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to On-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.95" spread="5.936"/>
                    <measurement group_id="O2" value="-8.46" spread="5.174"/>
                    <measurement group_id="O3" value="-6.46" spread="10.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Off-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.43" spread="7.852"/>
                    <measurement group_id="O2" value="1.36" spread="14.546"/>
                    <measurement group_id="O3" value="-1.82" spread="9.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0360</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1087</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2263</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5375</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Individual BBSS Score for Dyspareunia</title>
        <description>The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Individual BBSS Score for Dyspareunia</title>
          <description>The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>score on a scale per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" spread="24.15"/>
                    <measurement group_id="O2" value="36.5" spread="24.43"/>
                    <measurement group_id="O3" value="39.8" spread="21.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to On-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.50" spread="18.800"/>
                    <measurement group_id="O2" value="-14.75" spread="19.749"/>
                    <measurement group_id="O3" value="-9.83" spread="15.594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Off-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.50" spread="18.800"/>
                    <measurement group_id="O2" value="-14.75" spread="19.749"/>
                    <measurement group_id="O3" value="-9.83" spread="15.594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1017</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1927</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1017</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1927</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain</title>
        <description>The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain</title>
          <description>The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>score on a scale per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.3" spread="18.07"/>
                    <measurement group_id="O2" value="33.5" spread="17.85"/>
                    <measurement group_id="O3" value="32.7" spread="16.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to On-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.06" spread="11.132"/>
                    <measurement group_id="O2" value="-10.01" spread="15.200"/>
                    <measurement group_id="O3" value="-2.96" spread="15.782"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Off-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.87" spread="12.034"/>
                    <measurement group_id="O2" value="-13.09" spread="17.745"/>
                    <measurement group_id="O3" value="-8.26" spread="13.608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7508</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5507</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3993</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5821</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Prescription Analgesics Usage</title>
        <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Prescription Analgesics Usage</title>
          <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>pills per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" spread="18.13"/>
                    <measurement group_id="O2" value="14.9" spread="20.72"/>
                    <measurement group_id="O3" value="31.4" spread="52.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to On-Drug Cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.74" spread="14.897"/>
                    <measurement group_id="O2" value="-7.20" spread="15.948"/>
                    <measurement group_id="O3" value="-5.87" spread="27.753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7507</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8919</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Prescription Analgesics Usage</title>
        <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Prescription Analgesics Usage</title>
          <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.69" spread="71.980"/>
                    <measurement group_id="O2" value="-21.63" spread="76.530"/>
                    <measurement group_id="O3" value="-6.36" spread="174.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4780</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2354</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Non-Prescription Analgesics Usage</title>
        <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Non-Prescription Analgesics Usage</title>
          <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>pills per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" spread="29.05"/>
                    <measurement group_id="O2" value="15.4" spread="26.95"/>
                    <measurement group_id="O3" value="43.2" spread="98.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to On-Drug Cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="21.426"/>
                    <measurement group_id="O2" value="-12.79" spread="25.628"/>
                    <measurement group_id="O3" value="-6.81" spread="25.615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1140</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1636</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Non-Prescription Analgesics Usage</title>
        <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Non-Prescription Analgesics Usage</title>
          <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.06" spread="62.237"/>
                    <measurement group_id="O2" value="-22.80" spread="57.498"/>
                    <measurement group_id="O3" value="-31.49" spread="60.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1140</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0733</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Analgesics Usage</title>
        <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
        <population>ITT Population consisted of all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Analgesics Usage</title>
          <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
          <population>ITT Population consisted of all participants who were randomized and received study drug.</population>
          <units>pills per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8" spread="32.46"/>
                    <measurement group_id="O2" value="30.2" spread="35.09"/>
                    <measurement group_id="O3" value="74.6" spread="126.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to On-Drug Cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.96" spread="12.525"/>
                    <measurement group_id="O2" value="-19.99" spread="25.132"/>
                    <measurement group_id="O3" value="-12.67" spread="38.865"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1253</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3442</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Total Analgesics Usage</title>
        <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Total Analgesics Usage</title>
          <description>An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.88" spread="64.098"/>
                    <measurement group_id="O2" value="-51.96" spread="45.461"/>
                    <measurement group_id="O3" value="-36.05" spread="57.129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0303</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>On-Drug Cycle</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2864</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in BBSS Physician-Reported Scores</title>
        <description>BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.</description>
        <time_frame>Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug. Last observation carried forward (LOCF) approach was used to impute missing data in this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BBSS Physician-Reported Scores</title>
          <description>BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.</description>
          <population>ITT population included all participants who were randomized and received study drug. Last observation carried forward (LOCF) approach was used to impute missing data in this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PTS at Baseline (BL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.83"/>
                    <measurement group_id="O2" value="1.8" spread="0.77"/>
                    <measurement group_id="O3" value="1.5" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTS Change from BL to LOCF Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.76" spread="0.903"/>
                    <measurement group_id="O2" value="-0.95" spread="1.146"/>
                    <measurement group_id="O3" value="-0.43" spread="0.843"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTS Change from BL to ODI Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="0.954"/>
                    <measurement group_id="O2" value="-0.59" spread="0.712"/>
                    <measurement group_id="O3" value="-0.18" spread="1.006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IS at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.06"/>
                    <measurement group_id="O2" value="1.1" spread="1.05"/>
                    <measurement group_id="O3" value="0.8" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IS Change from BL to LOCF Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="1.007"/>
                    <measurement group_id="O2" value="-0.70" spread="0.923"/>
                    <measurement group_id="O3" value="-0.39" spread="0.988"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IS Change from BL to ODI Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="0.967"/>
                    <measurement group_id="O2" value="-0.59" spread="0.870"/>
                    <measurement group_id="O3" value="-0.41" spread="0.796"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PTS: LOCF Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4365</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PTS: LOCF Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1302</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PTS: ODI Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3591</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PTS: ODI Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0872</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>IS: LOCF Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4814</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>IS: LOCF Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9162</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>IS: ODI Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6607</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>IS: ODI Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9527</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score</title>
        <description>A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.</description>
        <time_frame>Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score</title>
          <description>A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" spread="27.68"/>
                    <measurement group_id="O2" value="66.6" spread="25.06"/>
                    <measurement group_id="O3" value="63.8" spread="29.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage change from BL to LOCF Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.11" spread="39.877"/>
                    <measurement group_id="O2" value="-46.10" spread="46.871"/>
                    <measurement group_id="O3" value="-17.02" spread="88.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change from BL to ODI Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.36" spread="46.552"/>
                    <measurement group_id="O2" value="-12.57" spread="52.070"/>
                    <measurement group_id="O3" value="118.34" spread="596.879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LOCF Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2812</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>LOCF Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5858</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>ODI Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4116</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ODI Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4252</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS)</title>
        <description>NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents &quot;no pain&quot; and 10 represents &quot;the worst pain possible&quot;. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)</time_frame>
        <population>ITT population included all participants who were randomized and received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
          </group>
          <group group_id="O2">
            <title>Telapristone Acetate 6 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
          </group>
          <group group_id="O3">
            <title>Telapristone Acetate 12 mg</title>
            <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS)</title>
          <description>NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents &quot;no pain&quot; and 10 represents &quot;the worst pain possible&quot;. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.</description>
          <population>ITT population included all participants who were randomized and received study drug.</population>
          <units>score on a scale per 28-day period</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAP Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" spread="13.26"/>
                    <measurement group_id="O2" value="64.7" spread="15.29"/>
                    <measurement group_id="O3" value="60.6" spread="13.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAP Change from BL to On-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.52" spread="4.527"/>
                    <measurement group_id="O2" value="-9.43" spread="14.480"/>
                    <measurement group_id="O3" value="-0.53" spread="10.544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAP Change from BL to Off-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.21" spread="10.125"/>
                    <measurement group_id="O2" value="-5.88" spread="27.822"/>
                    <measurement group_id="O3" value="3.04" spread="14.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EP Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.9" spread="72.48"/>
                    <measurement group_id="O2" value="136.2" spread="70.60"/>
                    <measurement group_id="O3" value="142.4" spread="70.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EP Change from BL to On-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.84" spread="39.777"/>
                    <measurement group_id="O2" value="-52.05" spread="39.140"/>
                    <measurement group_id="O3" value="-25.98" spread="40.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EP Change from BL to Off-Drug Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.91" spread="43.163"/>
                    <measurement group_id="O2" value="-27.06" spread="46.525"/>
                    <measurement group_id="O3" value="-29.02" spread="45.496"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>SAP: On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6131</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>SAP: On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7881</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>SAP: Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9376</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>SAP: Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6552</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EP: On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7143</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>EP: On-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2985</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EP: Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3162</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>EP: Off-Drug Cycle 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7503</p_value>
            <method>Wilcoxon Rank- Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks)</time_frame>
      <desc>AEs were reported according to the actual treatment received in Stage 2 and Stage 3.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Stage 2)</title>
          <description>Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.</description>
        </group>
        <group group_id="E2">
          <title>Telapristone Acetate 6 mg (Stage 2)</title>
          <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.</description>
        </group>
        <group group_id="E3">
          <title>Telapristone Acetate 12 mg (Stage 2)</title>
          <description>Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.</description>
        </group>
        <group group_id="E4">
          <title>Placebo:Telapristone Acetate 12 mg (Stage 3)</title>
          <description>Eligible participants who received placebo in Stage 2 and opted to receive up to 2 additional 16-week cycles of telapristone acetate (Proellex®) 12 mg/day in Stage 3.</description>
        </group>
        <group group_id="E5">
          <title>Telapristone Acetate 6 mg (Stage 3)</title>
          <description>Eligible participants who received telapristone acetate 6 mg in Stage 2 and opted to receive up to 2 additional 16-week cycles of telapristone acetate (Proellex®) 6 mg/day in Stage 3.</description>
        </group>
        <group group_id="E6">
          <title>Telapristone Acetate 12 mg (Stage 3)</title>
          <description>Eligible participants who received telapristone acetate 12 mg in Stage 2 and opted to receive 2 additional 16-week cycles of telapristone acetate (Proellex®) 12 mg/day in Stage 3.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <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="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Conjunctivitis infective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Smear cervix abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adnexa uteri pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Endometrial hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ovarian disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vaginal odour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hysterectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wisdom teeth removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT01728454
org study id: ZPE-202
nct id: NCT01728454
lead sponsor: 
has dmc: Yes
The primary purpose of this study is to determine the safety and efficacy of two oral doses
      of telapristone acetate administered to premenopausal women with pelvic pain associated with
      endometriosis confirmed within the last seven years and using prescription analgesics for
      symptomatic pain.
This study is a phase 2, 3-arm-study with an 18-week active dosing period and an option for
      participants to receive 2 additional 16-week cycles of active treatment at their randomized
      dose [6 mg or 12 mg/day]. Placebo participants who elect additional treatment will receive
      treatment at 12 mg/day. The treatment dose will remain double-blind. The study will be
      conducted in 3 stages. The first stage is a no treatment baseline assessment period. This
      stage will last as long as it takes to record at least one full menstrual cycle (ovulation
      until ovulation).

      For stage 2, following the run-in stage, at Visit 3, 60 participants will be randomized into
      one of 3 arms in a 1-1-1 fashion. The start of dosing should commence as soon as possible
      after ovulation following the end of the previous menstrual event.

      For stage 3, participants who are eligible to receive additional cycles of treatment and who
      elect to continue treatment will be scheduled within a week before the second expected menses
      (+/- 2 days), following the off-drug interval. Participants will receive 2 cycles of
      treatment separated by an off-drug interval (ODI), after which they will be followed until
      menses has returned.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea
time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
description: The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
measure: Change From Baseline in Individual BBSS Score for Dyspareunia
time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
description: The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..
measure: Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain
time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
description: The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
measure: Change From Baseline in Prescription Analgesics Usage
time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
description: An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
measure: Percentage Change From Baseline in Prescription Analgesics Usage
time frame: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
description: An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.
measure: Change From Baseline in Non-Prescription Analgesics Usage
time frame: Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
description: An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
measure: Percentage Change From Baseline in Non-Prescription Analgesics Usage
time frame: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
description: An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.
measure: Change From Baseline in Total Analgesics Usage
time frame: Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
description: An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
measure: Percentage Change From Baseline in Total Analgesics Usage
time frame: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
description: An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.
measure: Change From Baseline in BBSS Physician-Reported Scores
time frame: Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
description: BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.
measure: Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score
time frame: Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
description: A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.
measure: Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS)
time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
description: NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents "no pain" and 10 represents "the worst pain possible". Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
arm group label: Placebo
arm group type: Placebo Comparator
description: Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 milligrams (mg)/day separated by an off-drug interval (ODI) in Stage 3.
arm group label: Telapristone acetate 6 mg
arm group type: Experimental
description: Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.
arm group label: Telapristone acetate 12 mg
arm group type: Experimental
description: Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
intervention type: Drug
intervention name: Placebo
description: Placebo matching capsules, orally, once daily for 18 weeks.
arm group label: Placebo
intervention type: Drug
intervention name: Telapristone acetate
description: Telapristone acetate capsules, orally once daily for 18 weeks.
arm group label: Telapristone acetate 12 mg
arm group label: Telapristone acetate 6 mg
other name: Proellex®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 47 Years
healthy volunteers: No
last name: Anna Chan
role: Study Director
affiliation: Allergan
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country: United States
url: http://reprosrx.com
description: Sponsor corporate web page
responsible party type: Sponsor
mesh term: Endometriosis
provided document: 
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participant flow: 
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reported events: 
certain agreements: 
point of contact: 