<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/NCT03038100</url>
  </required_header>
  <id_info>
    <org_study_id>YO39523</org_study_id>
    <secondary_id>2016-003472-52</secondary_id>
    <nct_id>NCT03038100</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer</brief_title>
  <acronym>IMagyn050</acronym>
  <official_title>A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GOG Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Network of Gynaecological Oncological Trial Groups (ENGOT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the&#xD;
      efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo +&#xD;
      paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian&#xD;
      cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic&#xD;
      residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will&#xD;
      undergo neoadjuvant therapy followed by interval surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2017</start_date>
  <completion_date type="Actual">August 12, 2022</completion_date>
  <primary_completion_date type="Actual">February 8, 2022</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population</measure>
    <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
    <description>Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation</measure>
    <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
    <description>Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival - ITT Population</measure>
    <time_frame>From randomization up to death from any cause (up to approximately 59 months)</time_frame>
    <description>Overall Survival (OS) is defined as the time from randomization to death from any cause.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival - PD-L1-Positive Subpopulation</measure>
    <time_frame>From randomization up to death from any cause (up to approximately 59 months)</time_frame>
    <description>Overall Survival (OS) is defined as the time from randomization to death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population</measure>
    <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
    <description>OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population</measure>
    <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
    <description>OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population</measure>
    <time_frame>From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)</time_frame>
    <description>DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population</measure>
    <time_frame>From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)</time_frame>
    <description>DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group</measure>
    <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
    <description>Clinically-meaningful improvement defined as a &gt;=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group</measure>
    <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
    <description>Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a &gt;=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</measure>
    <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
    <description>Percentage of participants with clinical improvement, defined as &gt;= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</measure>
    <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
    <description>Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</measure>
    <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.</time_frame>
    <description>Percentage of participants with deterioration in patient-reported function and HRQoL, defined as &gt;= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Adverse Event</measure>
    <time_frame>From randomization up to approximately 59 months</time_frame>
    <description>Percentage of participants with at least one adverse event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Atezolizumab</measure>
    <time_frame>Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Concentration (Cmin) of Atezolizumab</measure>
    <time_frame>Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab</measure>
    <time_frame>Baseline to approximately 55 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1301</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Peritoneal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
    <arm_group_label>Placebo With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles</description>
    <arm_group_label>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
    <arm_group_label>Placebo With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle</description>
    <arm_group_label>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms</description>
    <arm_group_label>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
    <arm_group_label>Placebo With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab Placebo</intervention_name>
    <description>Placebo matching to atezolizumab on Day 1 of each 21-day cycle</description>
    <arm_group_label>Placebo With Paclitaxel, Carboplatin and Bevacizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC),&#xD;
             peritoneal primary carcinoma, or fallopian tube cancer&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
&#xD;
          -  Life expectancy greater than (&gt;) 12 weeks&#xD;
&#xD;
          -  For participants who receive therapeutic anticoagulation: stable anticoagulant regimen&#xD;
&#xD;
          -  Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor&#xD;
             specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed&#xD;
             tissue requirements at screening)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors&#xD;
             of low malignant potential)&#xD;
&#xD;
          -  Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal&#xD;
             cancer that was treated only with surgery (example [e.g.], participants with Stage IA&#xD;
             or Stage IB epithelial ovarian or fallopian tube cancers)&#xD;
&#xD;
          -  Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)&#xD;
&#xD;
          -  Received prior radiotherapy to any portion of the abdominal cavity or pelvis&#xD;
&#xD;
          -  Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant&#xD;
             chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer&#xD;
&#xD;
          -  Received any biological and/or targeted therapy (including but not limited to&#xD;
             vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management&#xD;
             and/or treatment of epithelial ovarian or peritoneal primary cancer&#xD;
&#xD;
          -  Have synchronous primary endometrial cancer&#xD;
&#xD;
          -  Have a prior history of primary endometrial cancer, except: Stage IA cancer;&#xD;
             superficial myometrial invasion, without lymphovascular invasion; grade less than (&lt;)&#xD;
             3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or&#xD;
             other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions&#xD;
&#xD;
          -  With the exception of non-melanoma skin cancer and other specific malignancies as&#xD;
             noted above, other invasive malignancies with any evidence of other cancers present&#xD;
             within the last 5 years or previous cancer treatment that contraindicates this&#xD;
             protocol therapy&#xD;
&#xD;
          -  Have a known hypersensitivity or allergy to biopharmaceutical agents produced in&#xD;
             Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab&#xD;
             formulations&#xD;
&#xD;
          -  Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or&#xD;
             anticipation of the need for a major surgical procedure during the course of the study&#xD;
             except participants who receive NACT and will need interval surgery. This may include&#xD;
             but is not limited to laparotomy.&#xD;
&#xD;
          -  Have prior allogeneic bone marrow transplantation or solid organ transplant&#xD;
&#xD;
          -  Have any other diseases, metabolic dysfunction, physical examination finding, or&#xD;
             clinical laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
             contraindicates the use of an investigational drug or that may affect the&#xD;
             interpretation of the results&#xD;
&#xD;
          -  Have any approved or investigational anti-cancer therapy, including chemotherapy or&#xD;
             hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives&#xD;
&#xD;
          -  Are administered treatment with any other investigational agent or participation in&#xD;
             another clinical study with anti-cancer therapeutic intent&#xD;
&#xD;
          -  Have core biopsy or other minor surgical procedures within 7 days prior to the first&#xD;
             dose of bevacizumab&#xD;
&#xD;
          -  Have known sensitivity to any component of bevacizumab&#xD;
&#xD;
          -  Have known sensitivity to any component of paclitaxel&#xD;
&#xD;
          -  Current treatment with anti-viral therapy for hepatitis B virus (HBV)&#xD;
&#xD;
          -  History of leptomeningeal disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph'S Hospital &amp; Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC - HAL</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology - HOPE Wilmot</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moores Cancer Center at UC San Diego Health</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAC + USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA - School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Sacramento</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Kaiser Permanente</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center Research Institute</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K. Permanente - San Fransisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olive View/Ucla Medical Center</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Walnut Creek</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital - Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danbury Hospital</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Connecticut Hematology and Oncology Associates; (ECHO)</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvester Comprehensive Cent.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute of Baptist Health, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Associates</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Health Care System; Cancer Research Program</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center; Oncology Research Dept-5C</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sudarshan K. Sharma, MD, Ltd.</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Research Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Vincent Health System; Gynecologic Oncology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospital &amp; Clinic; Division of Hematology/Oncology</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky; Gynecologic Oncology</name>
      <address>
        <city>Lexington</city>
        <state>Kansas</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woman's Hospital</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Partners Women's Health; Gyn-Oncology</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weinberg CA Inst Franklin Sq</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederick Health Hospital</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Health Bemidji</name>
      <address>
        <city>Bemidji</city>
        <state>Minnesota</state>
        <zip>56601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro-Minnesota Community Oncology Research Consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology Woodbury</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Dominic-Jackson Memorial Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic; Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Cancer Care</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-0600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of Hope</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MSK @Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper Health System; MD Anderson Cancer Center</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center; MSK Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jersey Shore Med Ctr; OB/GYN</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Name Hospital</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Gynecologic Oncology Associates, Inc.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womens Cancer Care Association</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Queens</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health; Monter Cancer Center</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Univ Medical Center; Obstetrics &amp; Gynecolog</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Downtown Chelsea Centre</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029-6574</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering CC</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Presbyterain Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Health Bismarck</name>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <zip>58506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45203-0542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Hospital; Cleveland Clinic Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus NCORP</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University, Arthur James Cancer Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma; Stephenson Oklahoma Canc Ctr</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cancer Specialists and Research Institute</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists, P.C.</name>
      <address>
        <city>Tigard</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Health System; Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee-Woman's Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Pennsylvania Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Gynecologic Oncology</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women &amp; Infants Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours - St. Francis Hospital</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monument Health Rapid City Hospital, Inc.</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Health System</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dell Seton Medical Center at UT-Seton Infusion Center; Research Department</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology Cancer Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center at Dallas; Department of Pathology</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers, LLP</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology San Antonio Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology- Northeast Texas</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dixie Medical Center</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute; Oncology</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, PC</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henrico Doctors' Hospital - Forest</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenandoah Oncology Associates</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DN Greenwald Center</name>
      <address>
        <city>Mukwonago</city>
        <state>Wisconsin</state>
        <zip>53149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Regional Cancer Center</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal North Shore Hospital; Northern Sydney Cancer Centre</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Hospital; Cabrini Foundation</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Center</name>
      <address>
        <city>North Melbourne</city>
        <state>Victoria</state>
        <zip>3051</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie</name>
      <address>
        <city>Graz</city>
        <zip>8020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Augustinus Wilrijk</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancer - INCa; Oncologia</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20560-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01317-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing City</city>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Second University Hospital</name>
      <address>
        <city>Chengdu City</city>
        <zip>610066</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing Cancer Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>400030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yet-sen University Cancer Center</name>
      <address>
        <city>Guangzhou City</city>
        <zip>510663</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's hospital school of medicine Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)</name>
      <address>
        <city>Nanjing City</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Affiliated to Southeast University</name>
      <address>
        <city>Nanjing</city>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangxi Cancer Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai City</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Central Hospital of Gynecology Obstetrics.</name>
      <address>
        <city>Tianjin City</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Zhejiang</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Olomouc; Onkologicka klinika</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ostrava; Fakultní nemocnice</name>
      <address>
        <city>Ostrava-Poruba</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gynekologicko-porodnicka klinika</name>
      <address>
        <city>Prague</city>
        <zip>120 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologicka klinika UK 2.LF a FN v Motole</name>
      <address>
        <city>Praha 5</city>
        <zip>15006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet; Onkologisk Klinik</name>
      <address>
        <city>København Ø</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <zip>70211</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopistollinen sairaala</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku Uni Central Hospital; Gynaecology Dept</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Sainte Catherine; Hopital De Semaine</name>
      <address>
        <city>Avignon</city>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>l'Hôpital privé du Confluent SAS</name>
      <address>
        <city>Nantes</city>
        <zip>44202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Des Diaconesses; Oncologie</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Rene Huguenin; CONSULT SPECIALISEES</name>
      <address>
        <city>St Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen; Zentrum Für Frauenheilkunde</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg; Frauenklinik</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Konstanz, Frauenklinik</name>
      <address>
        <city>Konstanz</city>
        <zip>78464</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Südstadt</name>
      <address>
        <city>Rostock</city>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm Am Michelsberg; Frauenklinik</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine</name>
      <address>
        <city>Athens</city>
        <zip>115 28</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni Hospital of Ioannina; Oncology Dept.</name>
      <address>
        <city>Ioannina</city>
        <zip>455 00</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.</name>
      <address>
        <city>Kifisia</city>
        <zip>145 64</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Patras Medical Oncology</name>
      <address>
        <city>Patras</city>
        <zip>265 04</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare</name>
      <address>
        <city>Thessaloniki</city>
        <zip>546 45</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillel Yaffe MC; Gynaecology</name>
      <address>
        <city>Hadera</city>
        <zip>3810101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center; Oncology Dept</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center; Obstetrics and Gynecology</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center; Obstetrics and Gynecology</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center; Oncology Inst.</name>
      <address>
        <city>Rehovot</city>
        <zip>7610001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Degli Infermi - Faenza; Oncologia Medica</name>
      <address>
        <city>Faenza</city>
        <state>Emilia-Romagna</state>
        <zip>48018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale Santa Maria Nuova; Oncologia</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Emilia-Romagna</state>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico A. Gemelli e C.I.C.; Area Salute della Donna</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.Spedali Civili; Ostetricia e Ginecologia</name>
      <address>
        <city>Brescia</city>
        <state>Lombardia</state>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS S. Raffaele; Ginecologia Oncologica</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. San Gerardo; Ginecologia</name>
      <address>
        <city>Monza</city>
        <state>Lombardia</state>
        <zip>20052</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Antonio Perrino; Oncologia Medica</name>
      <address>
        <city>Brindisi</city>
        <state>Puglia</state>
        <zip>72100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Silvestrini; Oncologia ed Ematologia</name>
      <address>
        <city>Perugia</city>
        <state>Umbria</state>
        <zip>06123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Aichi</city>
        <zip>466-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Shikoku Cancer Center</name>
      <address>
        <city>Ehime</city>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Ehime</city>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kure Medical Center</name>
      <address>
        <city>Hiroshima</city>
        <zip>737-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Hokkaido Cancer Center</name>
      <address>
        <city>Hokkaido</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Hyogo</city>
        <zip>673-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Iwate</city>
        <zip>028-3695</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima University Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Kanagawa</city>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Mie</city>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Miyagi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus HF; Radiumhospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0310</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej</name>
      <address>
        <city>Krakow</city>
        <zip>31-115</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej</name>
      <address>
        <city>Pozna?</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icu Spsk - 2</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow City Oncology Hospital #62</name>
      <address>
        <city>Moscovskaya Oblast</city>
        <state>Moskovskaja Oblast</state>
        <zip>143423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Dispensary of Ministry of Health of Tatarstan</name>
      <address>
        <city>Kazan</city>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N.Burdenko Main Military Clinical Hospital; Oncology Dept</name>
      <address>
        <city>Moscow</city>
        <zip>105229</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg Oncology &amp; Gynecology; City Clinical Oncology Dispensary</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitaria Parc Tauli; Servicio de Oncologia</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>8208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Hospital de Alcorcon; Servicio de Oncologia</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral Oncologico Clara Campal; Servicio de Oncología</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario la Fe; Servicio de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet; Servicio Oncologia</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni Hospital Linkoeping; Dept. of Oncology</name>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Hospital; Oncology - Radiumhemmet</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology</name>
      <address>
        <city>Adana</city>
        <zip>01230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara University Medical Faculty; Medikal Onkoloji</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü</name>
      <address>
        <city>Ankara</city>
        <zip>06490</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koc University Medical Faculty; Department of Gynecology &amp; Obstetrics</name>
      <address>
        <city>Istanbul</city>
        <zip>34010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Uni Istanbul Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>January 9, 2023</results_first_submitted>
  <results_first_submitted_qc>February 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2023</results_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</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>Fallopian Tube Neoplasms</mesh_term>
    <mesh_term>Peritoneal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03038100/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 6, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03038100/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study is considered &quot;Completed&quot; because all pre-planned study activities and analyses have been performed.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
          <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
        </group>
        <group group_id="P2">
          <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
          <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="650"/>
                <participants group_id="P2" count="651"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="650"/>
                <participants group_id="P2" count="651"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="289"/>
                <participants group_id="P2" count="272"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="305"/>
                <participants group_id="P2" count="311"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
          <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
        </group>
        <group group_id="B2">
          <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
          <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="650"/>
            <count group_id="B2" value="651"/>
            <count group_id="B3" value="1301"/>
          </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="59.3" spread="10.7"/>
                    <measurement group_id="B2" value="58.9" spread="10.5"/>
                    <measurement group_id="B3" value="59.1" spread="10.6"/>
                  </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="650"/>
                    <measurement group_id="B2" value="651"/>
                    <measurement group_id="B3" value="1301"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="598"/>
                    <measurement group_id="B2" value="589"/>
                    <measurement group_id="B3" value="1187"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="305"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="461"/>
                    <measurement group_id="B2" value="464"/>
                    <measurement group_id="B3" value="925"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population</title>
        <description>Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
        <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
        <population>Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population</title>
          <description>Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
          <population>Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="650"/>
                <count group_id="O2" value="651"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.37" lower_limit="17.22" upper_limit="19.75"/>
                    <measurement group_id="O2" value="19.48" lower_limit="18.14" upper_limit="20.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2785</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation</title>
        <description>Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
        <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
        <population>PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation</title>
          <description>Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.</description>
          <population>PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="393"/>
                <count group_id="O2" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.50" lower_limit="16.62" upper_limit="21.36"/>
                    <measurement group_id="O2" value="20.83" lower_limit="19.06" upper_limit="24.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0376</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival - ITT Population</title>
        <description>Overall Survival (OS) is defined as the time from randomization to death from any cause.</description>
        <time_frame>From randomization up to death from any cause (up to approximately 59 months)</time_frame>
        <population>Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival - ITT Population</title>
          <description>Overall Survival (OS) is defined as the time from randomization to death from any cause.</description>
          <population>Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="650"/>
                <count group_id="O2" value="651"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.59" lower_limit="45.31" upper_limit="49.74"/>
                    <measurement group_id="O2" value="50.53" lower_limit="46.26" upper_limit="NA">The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3432</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival - PD-L1-Positive Subpopulation</title>
        <description>Overall Survival (OS) is defined as the time from randomization to death from any cause.</description>
        <time_frame>From randomization up to death from any cause (up to approximately 59 months)</time_frame>
        <population>PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival - PD-L1-Positive Subpopulation</title>
          <description>Overall Survival (OS) is defined as the time from randomization to death from any cause.</description>
          <population>PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="393"/>
                <count group_id="O2" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.15" lower_limit="45.54" upper_limit="NA">The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">67.3% of the participants were censored and the median was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1316</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population</title>
        <description>OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.</description>
        <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
        <population>Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population</title>
          <description>OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.</description>
          <population>Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="650"/>
                <count group_id="O2" value="651"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7"/>
                    <measurement group_id="O2" value="92.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population</title>
        <description>OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.</description>
        <time_frame>From randomization until disease progression or death from any cause (up to approximately 55 months)</time_frame>
        <population>Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population</title>
          <description>OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.</description>
          <population>Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="393"/>
                <count group_id="O2" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.9"/>
                    <measurement group_id="O2" value="92.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population</title>
        <description>DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.</description>
        <time_frame>From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)</time_frame>
        <population>Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population</title>
          <description>DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.</description>
          <population>Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="650"/>
                <count group_id="O2" value="651"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.06" lower_limit="13.01" upper_limit="16.62"/>
                    <measurement group_id="O2" value="16.59" lower_limit="14.52" upper_limit="19.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population</title>
        <description>DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.</description>
        <time_frame>From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)</time_frame>
        <population>Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The PD-L1-positive subpopulation (defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization) who underwent primary tumor-reductive surgery.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population</title>
          <description>DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.</description>
          <population>Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The PD-L1-positive subpopulation (defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization) who underwent primary tumor-reductive surgery.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.44" lower_limit="12.71" upper_limit="19.29"/>
                    <measurement group_id="O2" value="17.71" lower_limit="15.01" upper_limit="19.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group</title>
        <description>Clinically-meaningful improvement defined as a &gt;=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).</description>
        <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
        <population>Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group</title>
          <description>Clinically-meaningful improvement defined as a &gt;=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).</description>
          <population>Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdominal Pain, Presurgical/Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.2"/>
                    <measurement group_id="O2" value="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="140"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4"/>
                    <measurement group_id="O2" value="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0"/>
                    <measurement group_id="O2" value="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3"/>
                    <measurement group_id="O2" value="54.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.1"/>
                    <measurement group_id="O2" value="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5"/>
                    <measurement group_id="O2" value="58.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7"/>
                    <measurement group_id="O2" value="48.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Completion of Treatment/Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0"/>
                    <measurement group_id="O2" value="51.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.3"/>
                    <measurement group_id="O2" value="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3"/>
                    <measurement group_id="O2" value="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.6"/>
                    <measurement group_id="O2" value="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Presurgical/Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.7"/>
                    <measurement group_id="O2" value="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="140"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0"/>
                    <measurement group_id="O2" value="59.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0"/>
                    <measurement group_id="O2" value="66.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9"/>
                    <measurement group_id="O2" value="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.5"/>
                    <measurement group_id="O2" value="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.3"/>
                    <measurement group_id="O2" value="56.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1"/>
                    <measurement group_id="O2" value="58.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3"/>
                    <measurement group_id="O2" value="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2"/>
                    <measurement group_id="O2" value="62.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.4"/>
                    <measurement group_id="O2" value="63.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1"/>
                    <measurement group_id="O2" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group</title>
        <description>Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a &gt;=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).</description>
        <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
        <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group</title>
          <description>Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a &gt;=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).</description>
          <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning, Presurgical/Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9"/>
                    <measurement group_id="O2" value="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4"/>
                    <measurement group_id="O2" value="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6"/>
                    <measurement group_id="O2" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2"/>
                    <measurement group_id="O2" value="36.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9"/>
                    <measurement group_id="O2" value="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7"/>
                    <measurement group_id="O2" value="42.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0"/>
                    <measurement group_id="O2" value="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Completion of Treatment/Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9"/>
                    <measurement group_id="O2" value="34.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.1"/>
                    <measurement group_id="O2" value="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8"/>
                    <measurement group_id="O2" value="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Presurgical/Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6"/>
                    <measurement group_id="O2" value="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                    <measurement group_id="O2" value="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9"/>
                    <measurement group_id="O2" value="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.4"/>
                    <measurement group_id="O2" value="39.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9"/>
                    <measurement group_id="O2" value="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1"/>
                    <measurement group_id="O2" value="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6"/>
                    <measurement group_id="O2" value="52.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9"/>
                    <measurement group_id="O2" value="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5"/>
                    <measurement group_id="O2" value="40.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3"/>
                    <measurement group_id="O2" value="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5"/>
                    <measurement group_id="O2" value="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5"/>
                    <measurement group_id="O2" value="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Presurgical/Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4"/>
                    <measurement group_id="O2" value="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.2"/>
                    <measurement group_id="O2" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.8"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3"/>
                    <measurement group_id="O2" value="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.6"/>
                    <measurement group_id="O2" value="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O2" value="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8"/>
                    <measurement group_id="O2" value="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Completion of Treatment/Early Termination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3"/>
                    <measurement group_id="O2" value="41.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7"/>
                    <measurement group_id="O2" value="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.1"/>
                    <measurement group_id="O2" value="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.5"/>
                    <measurement group_id="O2" value="47.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4"/>
                    <measurement group_id="O2" value="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Presurgical/Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7"/>
                    <measurement group_id="O2" value="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.2"/>
                    <measurement group_id="O2" value="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1"/>
                    <measurement group_id="O2" value="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                    <measurement group_id="O2" value="44.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.4"/>
                    <measurement group_id="O2" value="41.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8"/>
                    <measurement group_id="O2" value="42.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6"/>
                    <measurement group_id="O2" value="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Completion of Treatment/Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8"/>
                    <measurement group_id="O2" value="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3"/>
                    <measurement group_id="O2" value="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 9 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                    <measurement group_id="O2" value="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4"/>
                    <measurement group_id="O2" value="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 18 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, PresurgicalSurgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="46.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                    <measurement group_id="O2" value="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1"/>
                    <measurement group_id="O2" value="47.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0"/>
                    <measurement group_id="O2" value="59.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.4"/>
                    <measurement group_id="O2" value="61.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1"/>
                    <measurement group_id="O2" value="58.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0"/>
                    <measurement group_id="O2" value="61.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9"/>
                    <measurement group_id="O2" value="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.7"/>
                    <measurement group_id="O2" value="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7"/>
                    <measurement group_id="O2" value="41.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                    <measurement group_id="O2" value="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/HRQoL, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Presurgical/Surgery</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9096</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 4 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4662</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>2.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5237</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3826</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9893</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6892</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1324</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Completion of Treatment/Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9176</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7861</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4539</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>2.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4849</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7470</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>3.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0896</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>33.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.86</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.30</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Presurgical/Surgery</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7347</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Cycle 4 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0479</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0712</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8168</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6417</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8821</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2158</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Completion of Treatment/Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4762</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7585</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9985</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>1.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1067</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>5.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6171</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>5.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8084</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>23.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>-50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>94.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Presurgical/Surgery</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6802</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 4 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3470</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5564</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5000</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9778</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>1.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6005</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9900</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>2.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Completion of Treatment/Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2634</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>2.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9640</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4117</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3505</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>3.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2439</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>9.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1573</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>33.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.86</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.30</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role Functioning, Presurgical/Surgery</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1820</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 4 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0046</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.28</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0361</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0848</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.39</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1224</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3127</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6065</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>1.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1316</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7678</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7331</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.34</ci_lower_limit>
            <ci_upper_limit>2.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1235</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>10.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-84.09</ci_lower_limit>
            <ci_upper_limit>84.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.30</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Presurgical/Surgery</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7869</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 4 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2502</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 6 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5066</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8124</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4656</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>2.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6725</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5780</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Completion of Treatment/Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7611</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7588</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1428</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9802</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>2.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1967</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>8.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4795</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Respnders</param_type>
            <param_value>8.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-69.28</ci_lower_limit>
            <ci_upper_limit>85.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.30</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</title>
        <description>Percentage of participants with clinical improvement, defined as &gt;= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
        <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
        <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</title>
          <description>Percentage of participants with clinical improvement, defined as &gt;= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
          <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="473"/>
                <count group_id="O2" value="473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="456"/>
                    <count group_id="O2" value="444"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6"/>
                    <measurement group_id="O2" value="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="423"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7"/>
                    <measurement group_id="O2" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="414"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7"/>
                    <measurement group_id="O2" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="378"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4"/>
                    <measurement group_id="O2" value="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.1"/>
                    <measurement group_id="O2" value="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8"/>
                    <measurement group_id="O2" value="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Completion of Treatment/Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="366"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4"/>
                    <measurement group_id="O2" value="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                    <measurement group_id="O2" value="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7"/>
                    <measurement group_id="O2" value="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5"/>
                    <measurement group_id="O2" value="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8"/>
                    <measurement group_id="O2" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6"/>
                    <measurement group_id="O2" value="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="438"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="401"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5"/>
                    <measurement group_id="O2" value="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="377"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.1"/>
                    <measurement group_id="O2" value="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="311"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0"/>
                    <measurement group_id="O2" value="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8"/>
                    <measurement group_id="O2" value="51.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4"/>
                    <measurement group_id="O2" value="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.0"/>
                    <measurement group_id="O2" value="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1"/>
                    <measurement group_id="O2" value="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                    <measurement group_id="O2" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="442"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1"/>
                    <measurement group_id="O2" value="31.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6"/>
                    <measurement group_id="O2" value="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8"/>
                    <measurement group_id="O2" value="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6"/>
                    <measurement group_id="O2" value="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                    <measurement group_id="O2" value="48.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="367"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6"/>
                    <measurement group_id="O2" value="40.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7"/>
                    <measurement group_id="O2" value="41.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.2"/>
                    <measurement group_id="O2" value="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.2"/>
                    <measurement group_id="O2" value="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                    <measurement group_id="O2" value="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="454"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.7"/>
                    <measurement group_id="O2" value="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3"/>
                    <measurement group_id="O2" value="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="412"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3"/>
                    <measurement group_id="O2" value="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6"/>
                    <measurement group_id="O2" value="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3"/>
                    <measurement group_id="O2" value="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="368"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7"/>
                    <measurement group_id="O2" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1"/>
                    <measurement group_id="O2" value="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4"/>
                    <measurement group_id="O2" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1"/>
                    <measurement group_id="O2" value="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3"/>
                    <measurement group_id="O2" value="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0"/>
                    <measurement group_id="O2" value="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                    <measurement group_id="O2" value="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5"/>
                    <measurement group_id="O2" value="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5"/>
                    <measurement group_id="O2" value="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="368"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0"/>
                    <measurement group_id="O2" value="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6"/>
                    <measurement group_id="O2" value="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2"/>
                    <measurement group_id="O2" value="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3"/>
                    <measurement group_id="O2" value="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O2" value="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6651</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9927</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8209</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6507</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2596</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6532</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Completion Of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7592</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7424</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1912</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>2.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5526</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3609</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7527</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>3.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>-33.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>75.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3177</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4184</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5710</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3973</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5163</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6897</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Completion Of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5735</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1414</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8655</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3017</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2325</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1717</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analsyis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>16.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.49</ci_lower_limit>
            <ci_upper_limit>79.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4745</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5499</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8436</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5798</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9094</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4006</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4024</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8796</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4350</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6225</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5775</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>1.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2343</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>1.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0833</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>-66.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>4.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority</non_inferiority_desc>
            <p_value>0.6012</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2291</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6574</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9217</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7693</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6470</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Completion Of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6391</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0892</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0550</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0168</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0021</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7817</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>3.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>-33.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>75.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6646</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8677</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7670</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7487</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1882</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3015</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9059</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7125</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0947</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0686</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0175</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3376</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>2.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5637</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>-50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>23.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</title>
        <description>Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
        <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.</time_frame>
        <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</title>
          <description>Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
          <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="473"/>
                <count group_id="O2" value="473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="456"/>
                    <count group_id="O2" value="444"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1"/>
                    <measurement group_id="O2" value="56.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="423"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0"/>
                    <measurement group_id="O2" value="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="414"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8"/>
                    <measurement group_id="O2" value="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="378"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1"/>
                    <measurement group_id="O2" value="51.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.5"/>
                    <measurement group_id="O2" value="48.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6"/>
                    <measurement group_id="O2" value="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="366"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.8"/>
                    <measurement group_id="O2" value="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3"/>
                    <measurement group_id="O2" value="47.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2"/>
                    <measurement group_id="O2" value="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4"/>
                    <measurement group_id="O2" value="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                    <measurement group_id="O2" value="56.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8"/>
                    <measurement group_id="O2" value="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="438"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1"/>
                    <measurement group_id="O2" value="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="401"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.2"/>
                    <measurement group_id="O2" value="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="377"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9"/>
                    <measurement group_id="O2" value="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="311"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6"/>
                    <measurement group_id="O2" value="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6"/>
                    <measurement group_id="O2" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1"/>
                    <measurement group_id="O2" value="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5"/>
                    <measurement group_id="O2" value="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8"/>
                    <measurement group_id="O2" value="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="442"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                    <measurement group_id="O2" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6"/>
                    <measurement group_id="O2" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2"/>
                    <measurement group_id="O2" value="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                    <measurement group_id="O2" value="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1"/>
                    <measurement group_id="O2" value="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="367"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9"/>
                    <measurement group_id="O2" value="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3"/>
                    <measurement group_id="O2" value="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8"/>
                    <measurement group_id="O2" value="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.4"/>
                    <measurement group_id="O2" value="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                    <measurement group_id="O2" value="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6"/>
                    <measurement group_id="O2" value="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="454"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5"/>
                    <measurement group_id="O2" value="57.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4"/>
                    <measurement group_id="O2" value="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="412"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2"/>
                    <measurement group_id="O2" value="54.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2"/>
                    <measurement group_id="O2" value="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0"/>
                    <measurement group_id="O2" value="51.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2"/>
                    <measurement group_id="O2" value="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="368"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.0"/>
                    <measurement group_id="O2" value="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3"/>
                    <measurement group_id="O2" value="55.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6"/>
                    <measurement group_id="O2" value="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.6"/>
                    <measurement group_id="O2" value="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                    <measurement group_id="O2" value="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6"/>
                    <measurement group_id="O2" value="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.0"/>
                    <measurement group_id="O2" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                    <measurement group_id="O2" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4"/>
                    <measurement group_id="O2" value="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.9"/>
                    <measurement group_id="O2" value="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="368"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2"/>
                    <measurement group_id="O2" value="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9"/>
                    <measurement group_id="O2" value="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9"/>
                    <measurement group_id="O2" value="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3"/>
                    <measurement group_id="O2" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2"/>
                    <measurement group_id="O2" value="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9770</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7317</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6937</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3916</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3363</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6761</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6997</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3592</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8798</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3857</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6854</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.39</ci_lower_limit>
            <ci_upper_limit>1.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4533</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.11</ci_lower_limit>
            <ci_upper_limit>2.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>-33.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>75.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3658</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7619</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6580</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2726</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6973</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4470</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5150</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2103</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7969</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8300</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6987</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>2.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1441</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>17.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in proportion of Responders</param_type>
            <param_value>-66.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-100.00</ci_lower_limit>
            <ci_upper_limit>4.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7591</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5403</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2654</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5138</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2138</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2114</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3938</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7793</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7370</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9658</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3015</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.29</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7534</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>3.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/ QoL, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5637</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>16.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.49</ci_lower_limit>
            <ci_upper_limit>79.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1177</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2730</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9306</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8631</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0977</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0726</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9974</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7069</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3068</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>2.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1375</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>3.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9540</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>2.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4283</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>2.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>16.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-95.56</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2153</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7878</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1544</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8017</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4295</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9540</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7494</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6412</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8652</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6912</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5834</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9578</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>16.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social Functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5637</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>16.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.49</ci_lower_limit>
            <ci_upper_limit>79.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</title>
        <description>Percentage of participants with deterioration in patient-reported function and HRQoL, defined as &gt;= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
        <time_frame>From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.</time_frame>
        <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group</title>
          <description>Percentage of participants with deterioration in patient-reported function and HRQoL, defined as &gt;= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.</description>
          <population>PRO-evaluable population is defined as patients in the ITT population with a baseline and &gt;=1 post-baseline PRO assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="473"/>
                <count group_id="O2" value="473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="456"/>
                    <count group_id="O2" value="444"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1"/>
                    <measurement group_id="O2" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="423"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1"/>
                    <measurement group_id="O2" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="414"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4"/>
                    <measurement group_id="O2" value="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="378"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2"/>
                    <measurement group_id="O2" value="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1"/>
                    <measurement group_id="O2" value="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="366"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5"/>
                    <measurement group_id="O2" value="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6"/>
                    <measurement group_id="O2" value="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5"/>
                    <measurement group_id="O2" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                    <measurement group_id="O2" value="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                    <measurement group_id="O2" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3"/>
                    <measurement group_id="O2" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="438"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7"/>
                    <measurement group_id="O2" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="401"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1"/>
                    <measurement group_id="O2" value="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="377"/>
                    <count group_id="O2" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="311"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1"/>
                    <measurement group_id="O2" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="253"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0"/>
                    <measurement group_id="O2" value="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9"/>
                    <measurement group_id="O2" value="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4"/>
                    <measurement group_id="O2" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                    <measurement group_id="O2" value="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="37.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="442"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0"/>
                    <measurement group_id="O2" value="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.6"/>
                    <measurement group_id="O2" value="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8"/>
                    <measurement group_id="O2" value="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9"/>
                    <measurement group_id="O2" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5"/>
                    <measurement group_id="O2" value="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2"/>
                    <measurement group_id="O2" value="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="367"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2"/>
                    <measurement group_id="O2" value="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5"/>
                    <measurement group_id="O2" value="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0"/>
                    <measurement group_id="O2" value="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6"/>
                    <measurement group_id="O2" value="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="37.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="454"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="412"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                    <measurement group_id="O2" value="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2"/>
                    <measurement group_id="O2" value="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2"/>
                    <measurement group_id="O2" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="368"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3"/>
                    <measurement group_id="O2" value="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7"/>
                    <measurement group_id="O2" value="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9"/>
                    <measurement group_id="O2" value="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2"/>
                    <measurement group_id="O2" value="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1"/>
                    <measurement group_id="O2" value="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="413"/>
                    <count group_id="O2" value="403"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3"/>
                    <measurement group_id="O2" value="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="376"/>
                    <count group_id="O2" value="357"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                    <measurement group_id="O2" value="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3"/>
                    <measurement group_id="O2" value="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Completion of Treatment/ Early Termination Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="368"/>
                    <count group_id="O2" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5"/>
                    <measurement group_id="O2" value="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Post-Treatment Follow Up 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="236"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5"/>
                    <measurement group_id="O2" value="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Post-Treatment Follow Up 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9"/>
                    <measurement group_id="O2" value="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Post-Treatment Follow Up 9 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                    <measurement group_id="O2" value="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Post-Treatment Follow Up 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Post-Treatment Follow Up 18 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                    <measurement group_id="O2" value="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GHS/OoL Function, Post-Treatment Follow Up 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6063</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5739</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3792</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6022</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7893</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2125</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9661</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4299</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1542</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0363</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>6.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0814</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>8.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1915</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>38.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>66.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.39</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9818</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6263</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9407</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7700</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8458</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7028</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1391</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8002</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9751</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3811</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>2.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3950</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>3.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8993</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>5.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified</non_inferiority_desc>
            <p_value>0.3173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.34</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5988</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8859</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2531</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified Analysis</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0785</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0641</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0046</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.29</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8928</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6106</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.6159</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5372</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified Analysis</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0845</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>5.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1344</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>21.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Global health status/QoL, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.3173</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>50.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.34</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0260</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9179</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.5820</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9772</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1300</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0990</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7133</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1384</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2895</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2221</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>3.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0005</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.08</ci_lower_limit>
            <ci_upper_limit>26.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2171</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>34.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Role functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>16.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.49</ci_lower_limit>
            <ci_upper_limit>79.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 3 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4647</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 5 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7676</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 8 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1983</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 12 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.9874</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 16 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.4716</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Cycle 20 Day 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2041</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Completion of Treatment/ Early Termination Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.7771</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 3 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.8542</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 6 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1230</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 9 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.1089</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>3.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 12 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.0011</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.85</ci_lower_limit>
            <ci_upper_limit>18.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 18 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <p_value>0.2950</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>14.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social functioning, Post-Treatment Follow Up 24 Months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Stratified Analysis</non_inferiority_desc>
            <param_type>Difference in Proportion of Responders</param_type>
            <param_value>33.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.72</ci_lower_limit>
            <ci_upper_limit>100.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Adverse Event</title>
        <description>Percentage of participants with at least one adverse event.</description>
        <time_frame>From randomization up to approximately 59 months</time_frame>
        <population>Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
          </group>
          <group group_id="O2">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Adverse Event</title>
          <description>Percentage of participants with at least one adverse event.</description>
          <population>Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="644"/>
                <count group_id="O2" value="642"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.8"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Serum Concentration (Cmax) of Atezolizumab</title>
        <time_frame>Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose</time_frame>
        <population>PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Serum Concentration (Cmax) of Atezolizumab</title>
          <population>PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="538"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="538"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="487" spread="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="499"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="614" spread="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Serum Concentration (Cmin) of Atezolizumab</title>
        <time_frame>Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose</time_frame>
        <population>PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Serum Concentration (Cmin) of Atezolizumab</title>
          <population>PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="532"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="519"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146" spread="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="502"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149" spread="88.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242" spread="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286" spread="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab</title>
        <time_frame>Baseline to approximately 55 months</time_frame>
        <population>PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
            <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab</title>
          <population>PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="569"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline evaluable participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="563"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-baseline evaluable participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="569"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)</time_frame>
      <desc>All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious &amp; other adverse events reported based on safety population, which included participants who received any amount of any study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab</title>
          <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
        </group>
        <group group_id="E2">
          <title>Placebo With Paclitaxel, Carboplatin and Bevacizumab</title>
          <description>Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="272" subjects_at_risk="651"/>
                <counts group_id="E2" subjects_affected="289" subjects_at_risk="650"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="304" subjects_at_risk="642"/>
                <counts group_id="E2" subjects_affected="215" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>AGRANULOCYTOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="642"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="59" subjects_affected="54" subjects_at_risk="642"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GRANULOCYTOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>IMMUNE THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="642"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PANCYTOPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="642"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>THROMBOTIC MICROANGIOPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYELOSUPPRESSION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ANGINA UNSTABLE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ATRIAL TACHYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ATRIAL THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ATRIOVENTRICULAR BLOCK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CARDIOMYOPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CARDIOVASCULAR DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL ISCHAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYOCARDITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>OTOLITHIASIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ADDISON'S DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ADRENAL INSUFFICIENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>AUTOIMMUNE THYROIDITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERPARATHYROIDISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOTHYROIDISM</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SECONDARY ADRENOCORTICAL INSUFFICIENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>OCULAR MYASTHENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>OPTIC NEUROPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RETINAL VEIN OCCLUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ULCERATIVE KERATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL ADHESIONS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL HERNIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN LOWER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ANAL FISTULA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ANAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ASCITES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="642"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="642"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIARRHOEA HAEMORRHAGIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIVERTICULAR PERFORATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIVERTICULUM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DUODENAL PERFORATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ENTERITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ENTEROCOLITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ENTEROCUTANEOUS FISTULA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTRIC STENOSIS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL PERFORATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GINGIVAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HAEMORRHOIDAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ILEAL PERFORATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ILEUS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="642"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ILEUS PARALYTIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INCARCERATED INGUINAL HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INCARCERATED UMBILICAL HERNIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="642"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INTESTINAL PERFORATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LARGE INTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LARGE INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LARGE INTESTINE PERFORATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LOWER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MECHANICAL ILEUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="642"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>OBSTRUCTION GASTRIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>OESOPHAGITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ORAL LICHEN PLANUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PANCREATIC FISTULA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PANCREATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PERITONEAL ADHESIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PNEUMATOSIS INTESTINALIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RECTAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="642"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL PERFORATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SUBILEUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>THROMBOSIS MESENTERIC VESSEL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>UMBILICAL HERNIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CONDITION AGGRAVATED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEATH</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EARLY SATIETY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MUCOSAL INFLAMMATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MULTIPLE ORGAN DYSFUNCTION SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="31" subjects_affected="26" subjects_at_risk="642"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLESTASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DRUG-INDUCED LIVER INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEPATIC FUNCTION ABNORMAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEPATOTOXICITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>IMMUNE-MEDIATED HEPATITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>JAUNDICE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>JAUNDICE CHOLESTATIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LIVER INJURY</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEPATIC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAPHYLACTIC REACTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ANAPHYLACTIC SHOCK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CONTRAST MEDIA ALLERGY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CYTOKINE RELEASE SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>IMMUNE-MEDIATED ADVERSE REACTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SYSTEMIC IMMUNE ACTIVATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SARCOIDOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL ABSCESS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>APPENDICITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BACTERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BRONCHITIS VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM DIFFICILE COLITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM DIFFICILE INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ENCEPHALITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EPSTEIN-BARR VIRUS INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FOURNIER'S GANGRENE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS CLOSTRIDIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GINGIVITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HERPES ZOSTER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INFECTED LYMPHOCELE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INFECTIOUS MONONUCLEOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>KIDNEY INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LYMPHANGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MENINGITIS BACTERIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MENINGOENCEPHALITIS HERPETIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PELVIC ABSCESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PELVIC INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PERITONITIS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PERITONSILLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="642"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PNEUMONIA BACTERIAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PNEUMONIA VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>POSTOPERATIVE ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>POSTOPERATIVE WOUND INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PULPITIS DENTAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS ACUTE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>TONSILLITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="642"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>UROSEPSIS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VAGINAL ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VAGINAL CELLULITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VASCULAR DEVICE INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WOUND INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BACTERIAL SEPSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ANKLE FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CONCUSSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FASCIAL RUPTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FOOT FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FRACTURED SACRUM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL ANASTOMOTIC LEAK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HIP FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INCISION SITE IMPAIRED HEALING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INCISIONAL HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INFUSION RELATED REACTION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PERIPROSTHETIC FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PROCEDURAL INTESTINAL PERFORATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SPINAL COMPRESSION FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VAGINAL CUFF DEHISCENCE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WOUND COMPLICATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WOUND DEHISCENCE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>STOMA PROLAPSE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BLOOD POTASSIUM DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>C-REACTIVE PROTEIN INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEPATIC ENZYME INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INTERNATIONAL NORMALISED RATIO INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LIPASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LYMPHOCYTE COUNT DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="642"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ELECTROLYTE IMBALANCE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FOOD REFUSAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERCALCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERMAGNESAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>TYPE 1 DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FLANK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYOPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYOSITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SPINAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ANAPLASTIC ASTROCYTOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL STROMAL TUMOUR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INVASIVE DUCTAL BREAST CARCINOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PAPILLARY THYROID CANCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>APHASIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ATAXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CEREBELLAR INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CEREBRAL INFARCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>COGNITIVE DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEMENTIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEPRESSED LEVEL OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EPILEPSY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE INTRACRANIAL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC STROKE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYASTHENIA GRAVIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEUROPATHY PERIPHERAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PERIPHERAL MOTOR NEUROPATHY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PRESYNCOPE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SUBARACHNOID HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>TRANSIENT ISCHAEMIC ATTACK</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SUICIDAL IDEATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYDRONEPHROSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>IMMUNE-MEDIATED NEPHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEPHRITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEPHROPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PROTEINURIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>URINARY TRACT OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>UROGENITAL FISTULA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GLOMERULONEPHRITIS CHRONIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>FEMALE GENITAL TRACT FISTULA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VAGINAL FISTULA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEAVY MENSTRUAL BLEEDING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY DISTRESS SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ASPIRATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERVENTILATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT CONGESTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="642"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PULMONARY HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG ERUPTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ECZEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ERYTHEMA MULTIFORME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LICHEN PLANUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SKIN ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>STEVENS-JOHNSON SYNDROME</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>TOXIC SKIN ERUPTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>URTICARIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AORTIC DISSECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CIRCULATORY COLLAPSE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EMBOLISM</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="642"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EMBOLISM VENOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="642"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERTENSIVE URGENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LYMPHOCELE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LYMPHORRHOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="642"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ORTHOSTATIC HYPOTENSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>SHOCK HAEMORRHAGIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="642"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="637" subjects_at_risk="642"/>
                <counts group_id="E2" subjects_affected="637" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="468" subjects_affected="284" subjects_at_risk="642"/>
                <counts group_id="E2" events="440" subjects_affected="266" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="197" subjects_affected="69" subjects_at_risk="642"/>
                <counts group_id="E2" events="243" subjects_affected="76" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="477" subjects_affected="195" subjects_at_risk="642"/>
                <counts group_id="E2" events="507" subjects_affected="197" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="278" subjects_affected="137" subjects_at_risk="642"/>
                <counts group_id="E2" events="275" subjects_affected="134" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTHYROIDISM</sub_title>
                <counts group_id="E1" events="56" subjects_affected="51" subjects_at_risk="642"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOTHYROIDISM</sub_title>
                <counts group_id="E1" events="131" subjects_affected="118" subjects_at_risk="642"/>
                <counts group_id="E2" events="57" subjects_affected="54" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>VISION BLURRED</sub_title>
                <counts group_id="E1" events="34" subjects_affected="31" subjects_at_risk="642"/>
                <counts group_id="E2" events="48" subjects_affected="45" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" events="51" subjects_affected="39" subjects_at_risk="642"/>
                <counts group_id="E2" events="60" subjects_affected="49" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="253" subjects_affected="182" subjects_at_risk="642"/>
                <counts group_id="E2" events="241" subjects_affected="173" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="56" subjects_affected="49" subjects_at_risk="642"/>
                <counts group_id="E2" events="98" subjects_affected="66" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="297" subjects_affected="226" subjects_at_risk="642"/>
                <counts group_id="E2" events="334" subjects_affected="240" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="336" subjects_affected="223" subjects_at_risk="642"/>
                <counts group_id="E2" events="328" subjects_affected="199" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" events="39" subjects_affected="34" subjects_at_risk="642"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="54" subjects_affected="44" subjects_at_risk="642"/>
                <counts group_id="E2" events="61" subjects_affected="53" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="565" subjects_affected="325" subjects_at_risk="642"/>
                <counts group_id="E2" events="628" subjects_affected="337" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="138" subjects_affected="98" subjects_at_risk="642"/>
                <counts group_id="E2" events="106" subjects_affected="67" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="209" subjects_affected="150" subjects_at_risk="642"/>
                <counts group_id="E2" events="230" subjects_affected="156" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" events="29" subjects_affected="28" subjects_at_risk="642"/>
                <counts group_id="E2" events="39" subjects_affected="33" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="102" subjects_affected="78" subjects_at_risk="642"/>
                <counts group_id="E2" events="117" subjects_affected="79" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="297" subjects_affected="241" subjects_at_risk="642"/>
                <counts group_id="E2" events="339" subjects_affected="251" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="59" subjects_affected="35" subjects_at_risk="642"/>
                <counts group_id="E2" events="42" subjects_affected="33" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MUCOSAL INFLAMMATION</sub_title>
                <counts group_id="E1" events="49" subjects_affected="45" subjects_at_risk="642"/>
                <counts group_id="E2" events="36" subjects_affected="26" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="44" subjects_affected="40" subjects_at_risk="642"/>
                <counts group_id="E2" events="42" subjects_affected="40" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="124" subjects_affected="104" subjects_at_risk="642"/>
                <counts group_id="E2" events="75" subjects_affected="54" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="35" subjects_affected="33" subjects_at_risk="642"/>
                <counts group_id="E2" events="39" subjects_affected="32" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" events="60" subjects_affected="41" subjects_at_risk="642"/>
                <counts group_id="E2" events="59" subjects_affected="41" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="83" subjects_affected="63" subjects_at_risk="642"/>
                <counts group_id="E2" events="71" subjects_affected="55" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="169" subjects_affected="109" subjects_at_risk="642"/>
                <counts group_id="E2" events="140" subjects_affected="104" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>INFUSION RELATED REACTION</sub_title>
                <counts group_id="E1" events="116" subjects_affected="78" subjects_at_risk="642"/>
                <counts group_id="E2" events="71" subjects_affected="50" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="142" subjects_affected="91" subjects_at_risk="642"/>
                <counts group_id="E2" events="100" subjects_affected="59" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="149" subjects_affected="89" subjects_at_risk="642"/>
                <counts group_id="E2" events="93" subjects_affected="56" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BLOOD ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="50" subjects_affected="40" subjects_at_risk="642"/>
                <counts group_id="E2" events="48" subjects_affected="33" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>LYMPHOCYTE COUNT DECREASED</sub_title>
                <counts group_id="E1" events="55" subjects_affected="42" subjects_at_risk="642"/>
                <counts group_id="E2" events="44" subjects_affected="24" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="567" subjects_affected="177" subjects_at_risk="642"/>
                <counts group_id="E2" events="610" subjects_affected="168" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="267" subjects_affected="137" subjects_at_risk="642"/>
                <counts group_id="E2" events="329" subjects_affected="142" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="91" subjects_affected="84" subjects_at_risk="642"/>
                <counts group_id="E2" events="72" subjects_affected="68" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WEIGHT INCREASED</sub_title>
                <counts group_id="E1" events="51" subjects_affected="50" subjects_at_risk="642"/>
                <counts group_id="E2" events="46" subjects_affected="44" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="455" subjects_affected="143" subjects_at_risk="642"/>
                <counts group_id="E2" events="535" subjects_affected="122" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="160" subjects_affected="119" subjects_at_risk="642"/>
                <counts group_id="E2" events="154" subjects_affected="120" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="69" subjects_affected="46" subjects_at_risk="642"/>
                <counts group_id="E2" events="85" subjects_affected="52" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="97" subjects_affected="72" subjects_at_risk="642"/>
                <counts group_id="E2" events="94" subjects_affected="60" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" events="134" subjects_affected="92" subjects_at_risk="642"/>
                <counts group_id="E2" events="112" subjects_affected="83" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="63" subjects_affected="48" subjects_at_risk="642"/>
                <counts group_id="E2" events="61" subjects_affected="45" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="444" subjects_affected="286" subjects_at_risk="642"/>
                <counts group_id="E2" events="451" subjects_affected="285" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="97" subjects_affected="88" subjects_at_risk="642"/>
                <counts group_id="E2" events="115" subjects_affected="90" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="70" subjects_affected="45" subjects_at_risk="642"/>
                <counts group_id="E2" events="92" subjects_affected="51" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MUSCULAR WEAKNESS</sub_title>
                <counts group_id="E1" events="50" subjects_affected="45" subjects_at_risk="642"/>
                <counts group_id="E2" events="57" subjects_affected="44" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="205" subjects_affected="144" subjects_at_risk="642"/>
                <counts group_id="E2" events="239" subjects_affected="163" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" events="34" subjects_affected="34" subjects_at_risk="642"/>
                <counts group_id="E2" events="35" subjects_affected="32" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="110" subjects_affected="81" subjects_at_risk="642"/>
                <counts group_id="E2" events="121" subjects_affected="89" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="93" subjects_affected="76" subjects_at_risk="642"/>
                <counts group_id="E2" events="102" subjects_affected="80" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" events="66" subjects_affected="56" subjects_at_risk="642"/>
                <counts group_id="E2" events="52" subjects_affected="50" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="220" subjects_affected="149" subjects_at_risk="642"/>
                <counts group_id="E2" events="278" subjects_affected="179" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPOAESTHESIA</sub_title>
                <counts group_id="E1" events="63" subjects_affected="50" subjects_at_risk="642"/>
                <counts group_id="E2" events="78" subjects_affected="59" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NEUROPATHY PERIPHERAL</sub_title>
                <counts group_id="E1" events="175" subjects_affected="152" subjects_at_risk="642"/>
                <counts group_id="E2" events="196" subjects_affected="166" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" events="57" subjects_affected="47" subjects_at_risk="642"/>
                <counts group_id="E2" events="65" subjects_affected="40" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" events="201" subjects_affected="178" subjects_at_risk="642"/>
                <counts group_id="E2" events="186" subjects_affected="163" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="43" subjects_affected="38" subjects_at_risk="642"/>
                <counts group_id="E2" events="58" subjects_affected="49" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="41" subjects_affected="35" subjects_at_risk="642"/>
                <counts group_id="E2" events="41" subjects_affected="38" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="100" subjects_affected="89" subjects_at_risk="642"/>
                <counts group_id="E2" events="119" subjects_affected="97" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>PROTEINURIA</sub_title>
                <counts group_id="E1" events="172" subjects_affected="137" subjects_at_risk="642"/>
                <counts group_id="E2" events="178" subjects_affected="140" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="127" subjects_affected="102" subjects_at_risk="642"/>
                <counts group_id="E2" events="101" subjects_affected="80" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSPHONIA</sub_title>
                <counts group_id="E1" events="47" subjects_affected="44" subjects_at_risk="642"/>
                <counts group_id="E2" events="50" subjects_affected="44" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="112" subjects_affected="87" subjects_at_risk="642"/>
                <counts group_id="E2" events="110" subjects_affected="86" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="166" subjects_affected="136" subjects_at_risk="642"/>
                <counts group_id="E2" events="178" subjects_affected="139" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" events="38" subjects_affected="32" subjects_at_risk="642"/>
                <counts group_id="E2" events="40" subjects_affected="36" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" events="58" subjects_affected="47" subjects_at_risk="642"/>
                <counts group_id="E2" events="50" subjects_affected="41" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ALOPECIA</sub_title>
                <counts group_id="E1" events="393" subjects_affected="386" subjects_at_risk="642"/>
                <counts group_id="E2" events="415" subjects_affected="410" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" events="37" subjects_affected="35" subjects_at_risk="642"/>
                <counts group_id="E2" events="39" subjects_affected="33" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="108" subjects_affected="87" subjects_at_risk="642"/>
                <counts group_id="E2" events="74" subjects_affected="61" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="205" subjects_affected="152" subjects_at_risk="642"/>
                <counts group_id="E2" events="119" subjects_affected="99" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="67" subjects_affected="45" subjects_at_risk="642"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>URTICARIA</sub_title>
                <counts group_id="E1" events="49" subjects_affected="33" subjects_at_risk="642"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HOT FLUSH</sub_title>
                <counts group_id="E1" events="37" subjects_affected="35" subjects_at_risk="642"/>
                <counts group_id="E2" events="57" subjects_affected="48" subjects_at_risk="644"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="354" subjects_affected="225" subjects_at_risk="642"/>
                <counts group_id="E2" events="392" subjects_affected="263" subjects_at_risk="644"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03038100
org study id: YO39523
secondary id: 2016-003472-52
nct id: NCT03038100
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the
      efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo +
      paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian
      cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic
      residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will
      undergo neoadjuvant therapy followed by interval surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population
time frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
description: Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
measure: PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
time frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
description: Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
measure: Overall Survival - ITT Population
time frame: From randomization up to death from any cause (up to approximately 59 months)
description: Overall Survival (OS) is defined as the time from randomization to death from any cause.
measure: Overall Survival - PD-L1-Positive Subpopulation
time frame: From randomization up to death from any cause (up to approximately 59 months)
description: Overall Survival (OS) is defined as the time from randomization to death from any cause.
measure: Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
time frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
description: OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
measure: Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population
time frame: From randomization until disease progression or death from any cause (up to approximately 55 months)
description: OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
measure: Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
time frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
description: DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
measure: Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population
time frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
description: DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
measure: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
time frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
description: Clinically-meaningful improvement defined as a >=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).
measure: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
time frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
description: Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a >=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
measure: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
time frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
description: Percentage of participants with clinical improvement, defined as >= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
measure: Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
time frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
description: Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
measure: Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
time frame: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
description: Percentage of participants with deterioration in patient-reported function and HRQoL, defined as >= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
measure: Percentage of Participants With at Least One Adverse Event
time frame: From randomization up to approximately 59 months
description: Percentage of participants with at least one adverse event.
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
time frame: Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
time frame: Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
time frame: Baseline to approximately 55 months
arm group label: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
arm group type: Experimental
description: Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
arm group label: Placebo With Paclitaxel, Carboplatin and Bevacizumab
arm group type: Placebo Comparator
description: Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and placebo for additional 16 cycles.
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
arm group label: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
arm group label: Placebo With Paclitaxel, Carboplatin and Bevacizumab
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
arm group label: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
arm group label: Placebo With Paclitaxel, Carboplatin and Bevacizumab
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
arm group label: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
arm group label: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
arm group label: Placebo With Paclitaxel, Carboplatin and Bevacizumab
intervention type: Drug
intervention name: Atezolizumab Placebo
description: Placebo matching to atezolizumab on Day 1 of each 21-day cycle
arm group label: Placebo With Paclitaxel, Carboplatin and Bevacizumab
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Australia
country: Austria
country: Belgium
country: Brazil
country: China
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Norway
country: Poland
country: Russian Federation
country: Spain
country: Sweden
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Fallopian Tube Neoplasms
mesh term: Peritoneal Neoplasms
mesh term: Paclitaxel
mesh term: Bevacizumab
mesh term: Carboplatin
mesh term: Atezolizumab
mesh term: Antibodies, Monoclonal
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 