<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/NCT02203331</url>
  </required_header>
  <id_info>
    <org_study_id>15832</org_study_id>
    <secondary_id>2013-005090-53</secondary_id>
    <nct_id>NCT02203331</nct_id>
  </id_info>
  <brief_title>Bay98-7196, Dose Finding / POC Study</brief_title>
  <official_title>A Randomized, Double-blind, Double-dummy, Parallel- Group, Multi-center Phase IIb Study to Assess the Efficacy and Safety of Different Dose Combinations of an Aromatase Inhibitor and a Progestin in an Intravaginal Ring Versus Placebo and Leuprorelin / Leuprolide Acetate in Women With Symptomatic Endometriosis Over a 12-week Treatment Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new&#xD;
      treatment option for patients with endometriosis-associated pelvic pain&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2014</start_date>
  <completion_date type="Actual">October 24, 2016</completion_date>
  <primary_completion_date type="Actual">October 24, 2016</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (&gt;=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was &gt;=7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain &gt;=7 as Measured on NRS by Question 1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was &gt;=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain &gt;=4 as Measured on NRS by Question 1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was &gt;=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain &gt;=4 as Measured on NRS by Question 1 of ESD</measure>
    <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
    <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was &gt;=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levonorgestrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anastrozole 300 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anastrozole 600 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anastrozole 1050 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lupron / Leuprolide acetate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
    <arm_group_label>Anastrozole 1050 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_label>Anastrozole 300 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_label>Anastrozole 600 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_label>Levonorgestrel</arm_group_label>
    <arm_group_label>Lupron / Leuprolide acetate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levonorgestrel</intervention_name>
    <description>Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
    <arm_group_label>Levonorgestrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anastrozole</intervention_name>
    <description>Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection</description>
    <arm_group_label>Anastrozole 1050 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_label>Anastrozole 300 µg/d + Levonorgestrel</arm_group_label>
    <arm_group_label>Anastrozole 600 µg/d + Levonorgestrel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lupron / Leuprolide acetate</intervention_name>
    <description>Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection</description>
    <arm_group_label>Lupron / Leuprolide acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women18 years and above at the time of screening.&#xD;
&#xD;
          -  Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten&#xD;
             years but not less than 8 weeks before the screening visit In Japan, diagnosis based&#xD;
             on imaging (transvaginal ultrasound or MRI) also qualifies for inclusion.&#xD;
&#xD;
          -  Moderate to severe endometriosis-associated pelvic pain (EAPP) of ≥5 in the last 28&#xD;
             days before screening visit 1 measured on the numeric rating scale (NRS; i.e. 4-week&#xD;
             recall period).&#xD;
&#xD;
          -  At randomization: Adherence to the study procedures during the screening period, at&#xD;
             least 24 diary entries of ESD item 1 during the last 28 consecutive days before the&#xD;
             randomization visit, and a sum of the available ESD item 1 ('worst pain' on the daily&#xD;
             NRS) entries during this period of at least 98 (corresponding to an average score of ≥&#xD;
             3.5).&#xD;
&#xD;
          -  Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed&#xD;
             according to investigator's instruction.&#xD;
&#xD;
          -  Use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for&#xD;
             contraception from screening visit until the end of the study. This is not required if&#xD;
             adequate contraception is achieved by vasectomy of the partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation (less than three months since delivery, abortion, or lactation&#xD;
             before start of treatment)&#xD;
&#xD;
          -  Any diseases or conditions that can compromise the function of the body systems and&#xD;
             could result in altered absorption, excessive accumulation, impaired metabolism, or&#xD;
             altered excretion of the study drug&#xD;
&#xD;
          -  Any diseases or conditions that might interfere with the conduct of the study or the&#xD;
             interpretation of the results.&#xD;
&#xD;
          -  Any disease or condition that may worsen under hormonal treatment according to the&#xD;
             assessment and opinion of the investigator.&#xD;
&#xD;
          -  Undiagnosed abnormal genital bleeding&#xD;
&#xD;
          -  Wish for pregnancy during the study&#xD;
&#xD;
          -  Regular use of pain medication due to other underlying diseases&#xD;
&#xD;
          -  Non-responsiveness of endometriosis associated pelvic pain (EAPP) to GnRH-a or surgery&#xD;
             (partial response is not exclusionary).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158-2509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palos Heights</city>
        <state>Illinois</state>
        <zip>60463</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07754</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plainsboro</city>
        <state>New Jersey</state>
        <zip>08536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Villach</city>
        <state>Kärnten</state>
        <zip>9500</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Linz</city>
        <state>Oberösterreich</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Feldkirch</city>
        <state>Vorarlberg</state>
        <zip>6807</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
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  <location>
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  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer AG products conducted in Europe.</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>October 23, 2017</results_first_submitted>
  <results_first_submitted_qc>December 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 4, 2018</results_first_posted>
  <disposition_first_submitted>January 5, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>January 5, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 6, 2017</disposition_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anastrozole</mesh_term>
    <mesh_term>Leuprolide</mesh_term>
    <mesh_term>Levonorgestrel</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted in fourteen countries in Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Japan, Netherlands, Norway, Poland, Spain, Switzerland, United States, between 16 October 2014 (first participant first visit) and 24 October 2016 (last participant last visit).</recruitment_details>
      <pre_assignment_details>Overall, 605 participants were screened, of them 286 failed screening, remaining 319 participants were randomized and allocated to treatment, of them 14 participants did not receive study treatment for various reasons, remaining 305 participants were treated and 272 participants completed study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="P2">
          <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="P3">
          <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="P4">
          <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="P5">
          <title>Placebo IVR + Leuprorelin Injection</title>
          <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="P6">
          <title>Placebo IVR + Placebo Injection</title>
          <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="53"/>
                <participants group_id="P5" count="53"/>
                <participants group_id="P6" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="54"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="50"/>
                <participants group_id="P6" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="46"/>
                <participants group_id="P5" count="46"/>
                <participants group_id="P6" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="7"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="B2">
          <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="B3">
          <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="B4">
          <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="B5">
          <title>Placebo IVR + Leuprorelin Injection</title>
          <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="B6">
          <title>Placebo IVR + Placebo Injection</title>
          <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="B7">
          <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="52"/>
            <count group_id="B2" value="53"/>
            <count group_id="B3" value="55"/>
            <count group_id="B4" value="53"/>
            <count group_id="B5" value="53"/>
            <count group_id="B6" value="53"/>
            <count group_id="B7" value="319"/>
          </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="33.27" spread="7.4"/>
                    <measurement group_id="B2" value="32.96" spread="8.79"/>
                    <measurement group_id="B3" value="33.96" spread="5.73"/>
                    <measurement group_id="B4" value="33.72" spread="7.85"/>
                    <measurement group_id="B5" value="33.7" spread="6.29"/>
                    <measurement group_id="B6" value="34.89" spread="7.13"/>
                    <measurement group_id="B7" value="33.75" spread="7.23"/>
                  </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="52"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="53"/>
                    <measurement group_id="B6" value="53"/>
                    <measurement group_id="B7" value="319"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.19" spread="4.52"/>
                    <measurement group_id="B2" value="26.07" spread="6.71"/>
                    <measurement group_id="B3" value="23.84" spread="6.15"/>
                    <measurement group_id="B4" value="25.47" spread="5.68"/>
                    <measurement group_id="B5" value="25.47" spread="5.51"/>
                    <measurement group_id="B6" value="24.43" spread="5.08"/>
                    <measurement group_id="B7" value="24.91" spread="5.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Pain of the 7 Days With Worst Endometriosis Associated Pelvic Pain (EAPP)</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.8205" spread="1.171"/>
                    <measurement group_id="B2" value="7.4664" spread="0.9893"/>
                    <measurement group_id="B3" value="8.1905" spread="1.068"/>
                    <measurement group_id="B4" value="7.5429" spread="1.2568"/>
                    <measurement group_id="B5" value="7.8964" spread="1.1952"/>
                    <measurement group_id="B6" value="7.6886" spread="1.2389"/>
                    <measurement group_id="B7" value="7.7842" spread="1.1702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage of Days With Pain Greater Than or Equal to (&gt;=) 7</title>
          <description>Higher numbers are associated with more days of pain above the 7 on the 11-point (0-10) NRS.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.094" spread="35.5201"/>
                    <measurement group_id="B2" value="40.1521" spread="29.8714"/>
                    <measurement group_id="B3" value="55.1155" spread="33.7625"/>
                    <measurement group_id="B4" value="37.3044" spread="30.2894"/>
                    <measurement group_id="B5" value="48.7001" spread="33.6685"/>
                    <measurement group_id="B6" value="41.1847" spread="33.0479"/>
                    <measurement group_id="B7" value="45.8234" spread="33.1247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage of Days With Pain &gt;=4</title>
          <description>Higher numbers are associated with more days of pain above the 4 on the 11-point (0-10) NRS.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.0058" spread="19.3136"/>
                    <measurement group_id="B2" value="84.7239" spread="18.1713"/>
                    <measurement group_id="B3" value="89.029" spread="16.3667"/>
                    <measurement group_id="B4" value="85.8451" spread="17.9466"/>
                    <measurement group_id="B5" value="92.9141" spread="11.6008"/>
                    <measurement group_id="B6" value="80.4397" spread="20.1004"/>
                    <measurement group_id="B7" value="86.6042" spread="17.6568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
        <time_frame>Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)</time_frame>
        <population>The dose-response analysis was performed using the MCP-Mod method with groups containing LNG, ATZ + LNG, and Placebo. It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
          <population>The dose-response analysis was performed using the MCP-Mod method with groups containing LNG, ATZ + LNG, and Placebo. It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>units 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="39"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8974" spread="1.6416" lower_limit="1.6416"/>
                    <measurement group_id="O2" value="-1.6061" spread="1.6652" lower_limit="1.6652"/>
                    <measurement group_id="O3" value="-2.4014" spread="2.1833" lower_limit="2.1833"/>
                    <measurement group_id="O4" value="-2.2653" spread="1.5972" lower_limit="1.5972"/>
                    <measurement group_id="O5" value="-3.7679" spread="2.3507" lower_limit="1.8247"/>
                    <measurement group_id="O6" value="-2.293" spread="1.8247"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3875</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Emax</param_type>
            <param_value>0.1483</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2925</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2676</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Linear</param_type>
            <param_value>0.2484</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2975</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3211</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Sigmoidal Emax 1</param_type>
            <param_value>0.1995</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2922</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1721</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Sigmoidal Emax 2</param_type>
            <param_value>0.3467</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2994</dispersion_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
        <time_frame>Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)</time_frame>
        <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.</description>
          <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>units 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="39"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Treatment 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7582" spread="1.1518" lower_limit="1.1518"/>
                    <measurement group_id="O2" value="-0.6849" spread="1.3832" lower_limit="1.3832"/>
                    <measurement group_id="O3" value="-1.1463" spread="1.3992" lower_limit="1.3992"/>
                    <measurement group_id="O4" value="-1.0000" spread="1.2579" lower_limit="1.2579"/>
                    <measurement group_id="O5" value="-1.2071" spread="1.1978" lower_limit="1.1978"/>
                    <measurement group_id="O6" value="-0.9048" spread="1.1686" lower_limit="1.1686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6447" spread="1.4831" lower_limit="1.4831"/>
                    <measurement group_id="O2" value="-1.5126" spread="2.0161" lower_limit="2.0161"/>
                    <measurement group_id="O3" value="-2.1224" spread="2.2791" lower_limit="2.2791"/>
                    <measurement group_id="O4" value="-1.9959" spread="1.3978" lower_limit="1.3978"/>
                    <measurement group_id="O5" value="-2.8607" spread="2.0665" lower_limit="2.0665"/>
                    <measurement group_id="O6" value="-1.8022" spread="1.5131" lower_limit="1.5131"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.231</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Emax</param_type>
            <param_value>0.2736</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2878</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1865</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Linear</param_type>
            <param_value>0.3234</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2927</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1955</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Sigmoidal Emax 1</param_type>
            <param_value>0.3081</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2875</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1416</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Sigmoidal Emax 2</param_type>
            <param_value>0.3781</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2944</dispersion_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
        <time_frame>Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)</time_frame>
        <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
          <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>units 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="39"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="39"/>
              </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="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0938" spread="1.5314"/>
                    <measurement group_id="O2" value="5.7409" spread="1.3044"/>
                    <measurement group_id="O3" value="6.3694" spread="1.5300"/>
                    <measurement group_id="O4" value="5.7128" spread="1.4415"/>
                    <measurement group_id="O5" value="6.3962" spread="1.4575"/>
                    <measurement group_id="O6" value="5.6399" spread="1.5312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8472" spread="1.1905"/>
                    <measurement group_id="O2" value="-0.9009" spread="1.3434"/>
                    <measurement group_id="O3" value="-1.0931" spread="1.4002"/>
                    <measurement group_id="O4" value="-1.1257" spread="1.3317"/>
                    <measurement group_id="O5" value="-1.5315" spread="1.4809"/>
                    <measurement group_id="O6" value="-0.9777" spread="1.0680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5774" spread="1.6278"/>
                    <measurement group_id="O2" value="-1.5068" spread="1.8707"/>
                    <measurement group_id="O3" value="-1.7349" spread="1.9403"/>
                    <measurement group_id="O4" value="-1.9615" spread="1.3966"/>
                    <measurement group_id="O5" value="-2.6855" spread="2.0601"/>
                    <measurement group_id="O6" value="-1.8994" spread="1.3069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8001" spread="1.7687"/>
                    <measurement group_id="O2" value="-1.6411" spread="1.8071"/>
                    <measurement group_id="O3" value="-2.0112" spread="1.9575"/>
                    <measurement group_id="O4" value="-2.1268" spread="1.6877"/>
                    <measurement group_id="O5" value="-3.502" spread="2.3096"/>
                    <measurement group_id="O6" value="-2.2228" spread="1.4957"/>
                  </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>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5794</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Emax</param_type>
            <param_value>0.0081</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2832</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4301</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Linear</param_type>
            <param_value>0.1148</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2880</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5337</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Sigmoidal Emax 1</param_type>
            <param_value>0.0401</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2829</dispersion_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3396</p_value>
            <method>Contrast tests for dose-response model</method>
            <param_type>Sigmoidal Emax 2</param_type>
            <param_value>0.1835</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2899</dispersion_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (&gt;=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was &gt;=7.</description>
        <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
        <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (&gt;=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was &gt;=7.</description>
          <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="41"/>
                <count group_id="O6" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="41"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6034" spread="34.3126"/>
                    <measurement group_id="O2" value="27.5659" spread="27.6426"/>
                    <measurement group_id="O3" value="40.0813" spread="37.2694"/>
                    <measurement group_id="O4" value="23.9322" spread="28.6234"/>
                    <measurement group_id="O5" value="28.2015" spread="28.8430"/>
                    <measurement group_id="O6" value="25.1742" spread="24.2811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="41"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6257" spread="33.9315"/>
                    <measurement group_id="O2" value="22.8695" spread="28.3443"/>
                    <measurement group_id="O3" value="34.4364" spread="40.5623"/>
                    <measurement group_id="O4" value="14.9331" spread="23.8028"/>
                    <measurement group_id="O5" value="12.1320" spread="25.1638"/>
                    <measurement group_id="O6" value="14.1869" spread="17.7364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="41"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1293" spread="33.9451"/>
                    <measurement group_id="O2" value="19.9332" spread="26.0540"/>
                    <measurement group_id="O3" value="29.8103" spread="39.0434"/>
                    <measurement group_id="O4" value="14.3362" spread="25.6770"/>
                    <measurement group_id="O5" value="8.5351" spread="20.7819"/>
                    <measurement group_id="O6" value="12.7574" spread="18.5154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain &gt;=7 as Measured on NRS by Question 1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was &gt;=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
        <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
        <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain &gt;=7 as Measured on NRS by Question 1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was &gt;=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
          <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Treatment 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.6756" spread="22.6822"/>
                    <measurement group_id="O2" value="-12.5862" spread="21.4336"/>
                    <measurement group_id="O3" value="-15.0341" spread="21.0071"/>
                    <measurement group_id="O4" value="-13.3722" spread="19.6416"/>
                    <measurement group_id="O5" value="-19.8898" spread="25.9273"/>
                    <measurement group_id="O6" value="-16.0105" spread="19.0190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.1404" spread="28.5082"/>
                    <measurement group_id="O2" value="-17.2826" spread="29.0007"/>
                    <measurement group_id="O3" value="-20.6791" spread="30.2152"/>
                    <measurement group_id="O4" value="-22.3713" spread="24.4098"/>
                    <measurement group_id="O5" value="-36.3540" spread="34.9706"/>
                    <measurement group_id="O6" value="-26.9979" spread="24.9493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.4197" spread="31.4648"/>
                    <measurement group_id="O2" value="-20.8529" spread="28.3939"/>
                    <measurement group_id="O3" value="-25.3052" spread="33.5497"/>
                    <measurement group_id="O4" value="-22.9682" spread="28.8677"/>
                    <measurement group_id="O5" value="-39.9516" spread="33.8277"/>
                    <measurement group_id="O6" value="-28.4273" spread="29.6186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain &gt;=4 as Measured on NRS by Question 1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was &gt;=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
        <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
        <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain &gt;=4 as Measured on NRS by Question 1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was &gt;=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
          <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="41"/>
                <count group_id="O6" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="41"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.8037" spread="32.3658"/>
                    <measurement group_id="O2" value="69.3092" spread="27.8642"/>
                    <measurement group_id="O3" value="73.8956" spread="31.6868"/>
                    <measurement group_id="O4" value="70.6504" spread="27.8528"/>
                    <measurement group_id="O5" value="70.2066" spread="28.9333"/>
                    <measurement group_id="O6" value="65.9074" spread="30.0166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="41"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8199" spread="37.1217"/>
                    <measurement group_id="O2" value="57.8777" spread="34.7429"/>
                    <measurement group_id="O3" value="62.5822" spread="37.6989"/>
                    <measurement group_id="O4" value="52.6028" spread="35.6106"/>
                    <measurement group_id="O5" value="54.0965" spread="38.9629"/>
                    <measurement group_id="O6" value="49.487" spread="31.3566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="41"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.2902" spread="37.8585"/>
                    <measurement group_id="O2" value="57.0171" spread="34.3642"/>
                    <measurement group_id="O3" value="56.7691" spread="40.3803"/>
                    <measurement group_id="O4" value="50.7332" spread="36.2903"/>
                    <measurement group_id="O5" value="38.6986" spread="39.6045"/>
                    <measurement group_id="O6" value="47.0976" spread="35.3227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain &gt;=4 as Measured on NRS by Question 1 of ESD</title>
        <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was &gt;=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
        <time_frame>Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)</time_frame>
        <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O3">
            <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O4">
            <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
            <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O5">
            <title>Placebo IVR + Leuprorelin Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
          <group group_id="O6">
            <title>Placebo IVR + Placebo Injection</title>
            <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain &gt;=4 as Measured on NRS by Question 1 of ESD</title>
          <description>Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain &gt;=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was &gt;=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.</description>
          <population>It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.</population>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Treatment 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.8228" spread="20.4330"/>
                    <measurement group_id="O2" value="-15.4147" spread="24.0608"/>
                    <measurement group_id="O3" value="-15.1334" spread="22.5347"/>
                    <measurement group_id="O4" value="-15.1947" spread="21.1740"/>
                    <measurement group_id="O5" value="-21.4331" spread="23.4546"/>
                    <measurement group_id="O6" value="-14.5323" spread="20.9670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.4950" spread="28.1535"/>
                    <measurement group_id="O2" value="-26.8462" spread="32.6194"/>
                    <measurement group_id="O3" value="-26.4468" spread="34.4661"/>
                    <measurement group_id="O4" value="-33.2423" spread="27.3686"/>
                    <measurement group_id="O5" value="-37.7330" spread="36.9484"/>
                    <measurement group_id="O6" value="-30.9527" spread="25.4665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Treatment 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="35"/>
                    <count group_id="O5" value="40"/>
                    <count group_id="O6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.5498" spread="30.2853"/>
                    <measurement group_id="O2" value="-27.4770" spread="34.2051"/>
                    <measurement group_id="O3" value="-32.2600" spread="37.4997"/>
                    <measurement group_id="O4" value="-35.1119" spread="30.9316"/>
                    <measurement group_id="O5" value="-53.4266" spread="38.8452"/>
                    <measurement group_id="O6" value="-33.3421" spread="25.7105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study treatment up to 30 days after end of treatment (Day 114)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="E2">
          <title>ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="E3">
          <title>ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="E4">
          <title>ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection</title>
          <description>Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="E5">
          <title>Placebo IVR + Leuprorelin Injection</title>
          <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
        <group group_id="E6">
          <title>Placebo IVR + Placebo Injection</title>
          <description>Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy of unknown location</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Renal atrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhagic ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="40" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="35" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="38" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhagic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness transitory</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Eyelid rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyschezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Noninfectious peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hunger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pelvic mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Medical device discomfort</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhagic cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Medical device site discomfort</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Borrelia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Closed globe injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Colonoscopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Prothrombin time shortened</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Red blood cells urine positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urine bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nitrite urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urine ketone body present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Smear vaginal abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gardnerella test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Musculoskeletal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Schwannoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ovarian adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Device expulsion</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Loss of libido</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depressive symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast enlargement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspareunia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fibrocystic breast disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Galactorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hydrosalpinx</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypomenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ovarian rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Polymenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vaginal odour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Varicose veins pelvic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Adnexa uteri pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhagic ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Genital haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vaginal flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Abnormal withdrawal bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hand dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pigmentation disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wisdom teeth removal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="53"/>
              </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>For a period of five (5) years from the date of last disclosure under this Agreement. Recipient shall (a) maintain all Confidential Information in confidence and not disclose the same to any third party unless required to do so by court order or by law, in which case Recipient shall notify Bayer in writing prior to making such a disclosure, and (b) not use any Confidential Information for its own benefit or for the benefit of any third party.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>Bayer</organization>
      <phone>(+) 1-888-8422937</phone>
      <email>clinical-trials-contact@bayer.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/NCT02203331
org study id: 15832
secondary id: 2013-005090-53
nct id: NCT02203331
lead sponsor: 
has dmc: No
Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new
      treatment option for patients with endometriosis-associated pelvic pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD
time frame: Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
measure: Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD
time frame: Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
measure: Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
time frame: Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
measure: Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
time frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7.
measure: Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
time frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
measure: Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
time frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
measure: Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
time frame: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)
description: Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Levonorgestrel
arm group type: Experimental
description: Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Anastrozole 300 µg/d + Levonorgestrel
arm group type: Experimental
description: Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Anastrozole 600 µg/d + Levonorgestrel
arm group type: Experimental
description: Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Anastrozole 1050 µg/d + Levonorgestrel
arm group type: Experimental
description: Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Lupron / Leuprolide acetate
arm group type: Active Comparator
description: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
intervention type: Drug
intervention name: Placebo
description: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Anastrozole 1050 µg/d + Levonorgestrel
arm group label: Anastrozole 300 µg/d + Levonorgestrel
arm group label: Anastrozole 600 µg/d + Levonorgestrel
arm group label: Levonorgestrel
arm group label: Lupron / Leuprolide acetate
arm group label: Placebo
intervention type: Drug
intervention name: Levonorgestrel
description: Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Levonorgestrel
intervention type: Drug
intervention name: Anastrozole
description: Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
arm group label: Anastrozole 1050 µg/d + Levonorgestrel
arm group label: Anastrozole 300 µg/d + Levonorgestrel
arm group label: Anastrozole 600 µg/d + Levonorgestrel
intervention type: Drug
intervention name: Lupron / Leuprolide acetate
description: Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
arm group label: Lupron / Leuprolide acetate
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Austria
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: Finland
country: Germany
country: Italy
country: Japan
country: Netherlands
country: Norway
country: Poland
country: Spain
country: Switzerland
country: United States
country: Czech Republic
url: https://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer AG products conducted in Europe.
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Anastrozole
mesh term: Leuprolide
mesh term: Levonorgestrel
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certain agreements: 
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