<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/NCT01687712</url>
  </required_header>
  <id_info>
    <org_study_id>FIN3002</org_study_id>
    <nct_id>NCT01687712</nct_id>
  </id_info>
  <brief_title>Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF</brief_title>
  <official_title>Phase III Investigator and Assessor Blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA vs Gonal-f® RFF) in Normal Ovulatory Women 35 to 42 Years Old Undergoing in Vitro Fertilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fertility Biotech AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fertility Biotech AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle&#xD;
      stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f®&#xD;
      RFF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of the clinical pregnancy rate in the AFOLIA group compared to the US approved&#xD;
      Gonal-f® RFF Redi-ject group as the primary endpoint. Comparison of the number and size of&#xD;
      follicles, the number of cycle cancellation, the hormone parameters and adverse events in the&#xD;
      AFOLIA group compared to the Gonal-f® RFF group as secondary endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2013</start_date>
  <completion_date type="Actual">November 14, 2016</completion_date>
  <primary_completion_date type="Actual">September 10, 2015</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population</measure>
    <time_frame>Six weeks post embryo transfer</time_frame>
    <description>Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Pregnancy Rate After One Cycle of Treatment - PP Population</measure>
    <time_frame>Six weeks post embryo transfer</time_frame>
    <description>Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1</measure>
    <time_frame>Measured at discretionary visits between Days 9 and 15 after FSH starts</time_frame>
    <description>The number of days of r-hFSH stimulation a subject received during Cycle 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1</measure>
    <time_frame>Measured at discretionary visits between Days 9 and 15 after FSH starts.</time_frame>
    <description>The total dose of r-hFSH that subjects received during Cycle 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1</measure>
    <time_frame>Measured at discretionary visits between Days 9 and 15 after FSH starts.</time_frame>
    <description>The mean dose of r-hFSH that subjects received in a day during Cycle 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Oocytes Retrieved - Cycle 1</measure>
    <time_frame>Visit 8, 34-36 hours after hCG administration</time_frame>
    <description>The number of oocytes retrieved per subject, following hCG administration in Cycle 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1</measure>
    <time_frame>Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).</time_frame>
    <description>Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1</measure>
    <time_frame>Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).</time_frame>
    <description>Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Summary of Adverse Events (AEs) - Cycle 1</measure>
    <time_frame>Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).</time_frame>
    <description>Summary of AEs, including the number of subjects experiencing to following during Cycle 1:&#xD;
At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1</measure>
    <time_frame>Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).</time_frame>
    <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2</measure>
    <time_frame>Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).</time_frame>
    <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3</measure>
    <time_frame>Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).</time_frame>
    <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1</measure>
    <time_frame>Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).</time_frame>
    <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2</measure>
    <time_frame>Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).</time_frame>
    <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3</measure>
    <time_frame>Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).</time_frame>
    <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1100</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>AFOLIA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gonal-f® RFF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AFOLIA</intervention_name>
    <description>225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached</description>
    <arm_group_label>AFOLIA</arm_group_label>
    <other_name>Follitropin-alfa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gonal-f® RFF</intervention_name>
    <description>225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached</description>
    <arm_group_label>Gonal-f® RFF</arm_group_label>
    <other_name>Follitropin-alfa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  35 to 42 years of age&#xD;
&#xD;
          -  Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm&#xD;
             injection (ICSI)&#xD;
&#xD;
          -  Regular menstrual cycles (25-35 days)&#xD;
&#xD;
          -  History of a maximum of two fresh cycle treatments in the present series of assisted&#xD;
             reproductive technologies (ART) at the day of first screening (thawed cycles are not&#xD;
             subject to that criteria)&#xD;
&#xD;
          -  Body mass index (BMI) ≥18 and ≤38 kg/m2&#xD;
&#xD;
          -  Basal FSH &lt;12 IU/L (cycle day 2-5)&#xD;
&#xD;
          -  Antral follicle count (AFC) ≥ 10 to ≤20 follicles with a diameter of &lt;11mm (sum of&#xD;
             both ovaries) as measured on ultrasound (US) in the early follicular phase (menstrual&#xD;
             cycle day 2-5)&#xD;
&#xD;
          -  Documented history of infertility due to any of the following factors: tubal factor,&#xD;
             mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male&#xD;
             factor, unexplained infertility&#xD;
&#xD;
          -  Presence of both ovaries by ultrasonography and normal uterine cavity (confirmed by&#xD;
             hysterosalpingography, saline infusion sonography or hysteroscopy within 6 months&#xD;
             before randomization)&#xD;
&#xD;
          -  Male partner with semen analysis that is at least adequate for ICSI within 6 months&#xD;
             prior to patient beginning down-regulation (invasive or surgical sperm retrieval,&#xD;
             donor and/or cryopreserved sperm may be used)&#xD;
&#xD;
          -  Willingness to participate in the study and to comply with the study protocol&#xD;
&#xD;
          -  Signed informed consent prior to screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of pregnancy&#xD;
&#xD;
          -  History of or active polycystic ovary syndrome (PCOS)&#xD;
&#xD;
          -  AFC &gt;20 follicles with a diameter of &lt;11 mm (both ovaries combined) as measured on US&#xD;
             in the early follicular phase (menstrual cycle day 2-5)&#xD;
&#xD;
          -  History of &gt;2 unsuccessful fresh ART retrieval cycles&#xD;
&#xD;
          -  Presence of uncontrolled endocrine disorder&#xD;
&#xD;
          -  Previous history or presence of severe OHSS&#xD;
&#xD;
          -  Intrauterine fibroids ≥5 cm or otherwise clinically relevant pathology that could&#xD;
             impair embryo implantation or pregnancy continuation&#xD;
&#xD;
          -  History of recurrent spontaneous abortion (3 or more, even when unexplained)&#xD;
&#xD;
          -  Presence of severe endometriosis (ASRM stage 3 or stage 4) or hydrosalpinx&#xD;
&#xD;
          -  Neoplasia, including tumors of the hypothalamus and pituitary gland&#xD;
&#xD;
          -  Abnormal bleeding of undetermined origin&#xD;
&#xD;
          -  History of extrauterine pregnancy in the previous 3 months&#xD;
&#xD;
          -  Known allergy or hypersensitivity to progesterone or to any of the excipients&#xD;
             (including peanut oil) of the additional study medications (GnRH agonist, Ovidrel®,&#xD;
             and Crinone 8%®)&#xD;
&#xD;
          -  History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes&#xD;
             retrieved in a previous attempt)&#xD;
&#xD;
          -  Any hormonal treatment within 1 month before the start of the FSH treatment, with the&#xD;
             exception of levothyroxine)&#xD;
&#xD;
          -  Egg donor&#xD;
&#xD;
          -  Administration of other investigational products within the previous month&#xD;
&#xD;
          -  Clinically abnormal findings at Visit 1&#xD;
&#xD;
          -  Concomitant participation in another study protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julian Jenkins, DM FRCOG</last_name>
    <role>Study Director</role>
    <affiliation>Fertility Biotech AG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Research Group</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HRC Fertility</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reproductive Associates of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FL Fertility Institution</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Reproductive Specialists</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fertility Centers of Illinois</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>In Via Fertility Specialists</name>
      <address>
        <city>Hoffman Estate</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shady Grove Fertility RSC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Center for Reproductive Medicine</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper Institute of Reproductive Hormonal Disorders, P.C.</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Reproductive Health</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Reproductive Medicine</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Main Line Fertility Center</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shady Grove Fertility RSC, Chesterbrook, PA</name>
      <address>
        <city>Chesterbrook</city>
        <state>Pennsylvania</state>
        <zip>19087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Penn</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fertility Associates of Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Fertility Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Assisted Reproduction</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>75022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fertility Specialists of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Fertility Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of Reproducitve Medicine</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jones Institute for Reproductive Medicine</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>September 20, 2017</results_first_submitted>
  <results_first_submitted_qc>September 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2017</results_first_posted>
  <last_update_submitted>October 31, 2017</last_update_submitted>
  <last_update_submitted_qc>October 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>In vitro fertilization</keyword>
  <keyword>Controlled ovarian stimulation</keyword>
  <keyword>Follitropin</keyword>
  <keyword>AFOLIA</keyword>
  <keyword>Finox</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1548 subjects were enrolled, 1101 subjects were randomized and 1100 received Investigational Medicinal Product (IMP) at 22 investigational sites in the United States.</recruitment_details>
      <pre_assignment_details>After the informed consent was signed, each subject received a subject identification number and underwent the down-regulation procedure. After a successful downregulation, subjects were centrally randomized in a 1:1 ratio to one of the treatment groups, AFOLIA or Gonal-f®RFF.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AFOLIA</title>
          <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="P2">
          <title>Gonal-f® RFF</title>
          <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Cycle 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="549"/>
                <participants group_id="P2" count="551"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received hCG</title>
              <participants_list>
                <participants group_id="P1" count="516"/>
                <participants group_id="P2" count="520"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Oocyte/Ovum Pick Up</title>
              <participants_list>
                <participants group_id="P1" count="513"/>
                <participants group_id="P2" count="517"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Fertilization Performed</title>
              <participants_list>
                <participants group_id="P1" count="508"/>
                <participants group_id="P2" count="512"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Embryo Transfer</title>
              <participants_list>
                <participants group_id="P1" count="466"/>
                <participants group_id="P2" count="483"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Biochemical Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="203"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clinical Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="448"/>
                <participants group_id="P2" count="429"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not Biochemically Pregnant</title>
              <participants_list>
                <participants group_id="P1" count="386"/>
                <participants group_id="P2" count="348"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Early Pregnancy Loss</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ectopic Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Heterotropic Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscarriage/Spontaneous Abortion</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Abortion</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intrauterine Fetal Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Cycle 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received hCG</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Oocyte/Ovum Pick Up</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Fertilization Performed</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Embryo Transfer</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Biochemical Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clinical Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not Biochemically Pregnant</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Early Pregnancy Loss</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ectopic Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Still Birth</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscarriage/Spontaneous Abortion</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Cycle 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received hCG</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Ooctye/Ovum Pick-Up</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Fertilization Performed</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Embryo Transfer</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Biochemically Pregnant</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clinical Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not Biochemically Pregnant</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Early Pregnancy Loss</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ectopic Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscarriage/Spontaneous Abortion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intention to treat population, defined as all randomized subjects who received at least one dose of the study treatment, based on their randomization.</population>
      <group_list>
        <group group_id="B1">
          <title>AFOLIA</title>
          <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="B2">
          <title>Gonal-f® RFF</title>
          <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</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="549"/>
            <count group_id="B2" value="551"/>
            <count group_id="B3" value="1100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.7" spread="2.16"/>
                    <measurement group_id="B2" value="37.8" spread="2.18"/>
                    <measurement group_id="B3" value="37.8" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>35-37</title>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                    <measurement group_id="B2" value="276"/>
                    <measurement group_id="B3" value="551"/>
                  </measurement_list>
                </category>
                <category>
                  <title>38-40</title>
                  <measurement_list>
                    <measurement group_id="B1" value="201"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="395"/>
                  </measurement_list>
                </category>
                <category>
                  <title>41-42</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="549"/>
                    <measurement group_id="B2" value="551"/>
                    <measurement group_id="B3" value="1100"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="452"/>
                    <measurement group_id="B2" value="473"/>
                    <measurement group_id="B3" value="925"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="435"/>
                    <measurement group_id="B2" value="440"/>
                    <measurement group_id="B3" value="875"/>
                  </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="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (m)</title>
          <population>Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="550"/>
                    <count group_id="B3" value="1099"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.643" spread="0.0660"/>
                    <measurement group_id="B2" value="1.642" spread="0.0684"/>
                    <measurement group_id="B3" value="1.642" spread="0.0672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <population>Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.</population>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="541"/>
                    <count group_id="B2" value="546"/>
                    <count group_id="B3" value="1087"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.01" spread="13.803"/>
                    <measurement group_id="B2" value="71.12" spread="13.844"/>
                    <measurement group_id="B3" value="70.57" spread="13.828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (kg/m^2)</title>
          <population>Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="541"/>
                    <count group_id="B2" value="545"/>
                    <count group_id="B3" value="1086"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.92" spread="4.738"/>
                    <measurement group_id="B2" value="26.38" spread="4.784"/>
                    <measurement group_id="B3" value="26.15" spread="4.765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI Category (kg/m^2)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt;=18 to &lt;25</title>
                  <measurement_list>
                    <measurement group_id="B1" value="279"/>
                    <measurement group_id="B2" value="245"/>
                    <measurement group_id="B3" value="524"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=25 to &lt;30</title>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="184"/>
                    <measurement group_id="B3" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=30 to &lt;=38</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;38</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Cause of Infertility</title>
          <description>Subjects can have more than one factor that causes infertility, therefore percentages may add up to more than 100.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Unexplained Infertility</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="225"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male Factor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tubal Factor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Endometriosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infertility Duration</title>
          <population>Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="548"/>
                    <count group_id="B2" value="550"/>
                    <count group_id="B3" value="1098"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.1" spread="4.61"/>
                    <measurement group_id="B2" value="4.2" spread="4.54"/>
                    <measurement group_id="B3" value="4.1" spread="4.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of previous fresh ART cycles [N(%)]</title>
          <description>Number of previous Assisted Reproductive Technology (ART) cycles a subject had prior to starting Cycle 1.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="549"/>
                    <count group_id="B2" value="551"/>
                    <count group_id="B3" value="1100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="441"/>
                    <measurement group_id="B2" value="440"/>
                    <measurement group_id="B3" value="881"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FSH at screening</title>
          <description>Measure of Follicle Stimulating Hormone (FSH) at screening.</description>
          <population>Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.</population>
          <units>international units (IU)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="548"/>
                    <count group_id="B2" value="550"/>
                    <count group_id="B3" value="1098"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.98" spread="4.636"/>
                    <measurement group_id="B2" value="7.76" spread="2.433"/>
                    <measurement group_id="B3" value="7.87" spread="3.700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LH at screening</title>
          <description>Measure of Luteinizing Hormone (LH) at screening.</description>
          <population>Number of subjects analysed is less than the number of subjects in the ITT population due to missing data.</population>
          <units>international units (IU)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="385"/>
                    <count group_id="B3" value="762"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.77" spread="3.36"/>
                    <measurement group_id="B2" value="5.74" spread="2.44"/>
                    <measurement group_id="B3" value="5.76" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population</title>
        <description>Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.</description>
        <time_frame>Six weeks post embryo transfer</time_frame>
        <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population</title>
          <description>Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.</description>
          <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="435"/>
                    <measurement group_id="O2" value="413"/>
                  </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>The null and alternative hypotheses are as follows:&#xD;
H0: p2- p1 &gt; ∆ and H1: p2- p1 ≤ ∆,&#xD;
where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (&amp; Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>8.7</ci_upper_limit>
            <estimate_desc>Note that &quot;risk&quot; in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Pregnancy Rate After One Cycle of Treatment - PP Population</title>
        <description>Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.</description>
        <time_frame>Six weeks post embryo transfer</time_frame>
        <population>Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Pregnancy Rate After One Cycle of Treatment - PP Population</title>
          <description>Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.</description>
          <population>Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="486"/>
                <count group_id="O2" value="494"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="378"/>
                    <measurement group_id="O2" value="369"/>
                  </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>The null and alternative hypotheses are as follows:&#xD;
H0: p2- p1 &gt; ∆ and H1: p2- p1 ≤ ∆,&#xD;
where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (&amp; Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>8.1</ci_upper_limit>
            <estimate_desc>Note that &quot;risk&quot; in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1</title>
        <description>The number of days of r-hFSH stimulation a subject received during Cycle 1.</description>
        <time_frame>Measured at discretionary visits between Days 9 and 15 after FSH starts</time_frame>
        <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1</title>
          <description>The number of days of r-hFSH stimulation a subject received during Cycle 1.</description>
          <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="1.72"/>
                    <measurement group_id="O2" value="11.0" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1</title>
        <description>The total dose of r-hFSH that subjects received during Cycle 1.</description>
        <time_frame>Measured at discretionary visits between Days 9 and 15 after FSH starts.</time_frame>
        <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1</title>
          <description>The total dose of r-hFSH that subjects received during Cycle 1.</description>
          <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>international unit (IU)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3209.2" spread="1008.05"/>
                    <measurement group_id="O2" value="3343.6" spread="1005.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1</title>
        <description>The mean dose of r-hFSH that subjects received in a day during Cycle 1.</description>
        <time_frame>Measured at discretionary visits between Days 9 and 15 after FSH starts.</time_frame>
        <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1</title>
          <description>The mean dose of r-hFSH that subjects received in a day during Cycle 1.</description>
          <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>international unit (IU)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292.1" spread="57.90"/>
                    <measurement group_id="O2" value="297.5" spread="56.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Oocytes Retrieved - Cycle 1</title>
        <description>The number of oocytes retrieved per subject, following hCG administration in Cycle 1.</description>
        <time_frame>Visit 8, 34-36 hours after hCG administration</time_frame>
        <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Oocytes Retrieved - Cycle 1</title>
          <description>The number of oocytes retrieved per subject, following hCG administration in Cycle 1.</description>
          <population>Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Oocytes retrieved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="513"/>
                <count group_id="O2" value="517"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="6.76"/>
                    <measurement group_id="O2" value="11.2" spread="6.63"/>
                  </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>The null and alternative hypotheses are as follows:&#xD;
H0: p2- p1 = 0 and H1: p2- p1 ≠0,&#xD;
where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Comparisons were tested against a null of zero at the two-side 5% significance level.</non_inferiority_desc>
            <p_value>0.612</p_value>
            <p_value_desc>P-values are based upon Type III sums of squares.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Treatment group and Site are included as factors.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1</title>
        <description>Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.</description>
        <time_frame>Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1</title>
          <description>Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Subjects who reported at least one dermal response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subjects who reported no dermal responses</title>
                  <measurement_list>
                    <measurement group_id="O1" value="512"/>
                    <measurement group_id="O2" value="509"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1</title>
        <description>Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction</description>
        <time_frame>Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1</title>
          <description>Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No evidence of irritation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimal erythema, barely perceptible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Definited Erythema, readily visible; minimal edema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Definite Edema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Summary of Adverse Events (AEs) - Cycle 1</title>
        <description>Summary of AEs, including the number of subjects experiencing to following during Cycle 1:&#xD;
At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication</description>
        <time_frame>Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Summary of Adverse Events (AEs) - Cycle 1</title>
          <description>Summary of AEs, including the number of subjects experiencing to following during Cycle 1:&#xD;
At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403"/>
                    <measurement group_id="O2" value="391"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one treatment related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202"/>
                    <measurement group_id="O2" value="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one serious adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one AE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one AE due to pregnancy complication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1</title>
        <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
        <time_frame>Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1</title>
          <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Number of Subjects with OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Mild OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Moderate OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Severe OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2</title>
        <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
        <time_frame>Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2</title>
          <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Number of Subjects with OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Mild OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Moderate OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Severe OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3</title>
        <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
        <time_frame>Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3</title>
          <description>Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Number of Subjects with OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Mild OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Moderate OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects with Severe OHSS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1</title>
        <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.</description>
        <time_frame>Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1</title>
          <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="549"/>
                <count group_id="O2" value="551"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="549"/>
                    <count group_id="O2" value="551"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="543"/>
                    <count group_id="O2" value="541"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="463"/>
                    <count group_id="O2" value="478"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="449"/>
                    <count group_id="O2" value="471"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2</title>
        <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.</description>
        <time_frame>Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2</title>
          <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3</title>
        <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.</description>
        <time_frame>Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).</time_frame>
        <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.</population>
        <group_list>
          <group group_id="O1">
            <title>AFOLIA</title>
            <description>One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
          <group group_id="O2">
            <title>Gonal-f® RFF</title>
            <description>One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3</title>
          <description>Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.</description>
          <population>Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>AFOLIA - Cycle 1</title>
          <description>Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="E2">
          <title>Gonal-f® RFF - Cycle 1</title>
          <description>Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="E3">
          <title>AFOLIA - Cycle 2</title>
          <description>Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="E4">
          <title>Gonal-f® RFF - Cycle 2</title>
          <description>Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="E5">
          <title>AFOLIA - Cycle 3</title>
          <description>Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
        <group group_id="E6">
          <title>Gonal-f® RFF - Cycle 3</title>
          <description>Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Foetal heart rate deceleration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Accessory auricle</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cardiac septal defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cleft palate</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Congenital skin dimples</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cytogenetic abnormality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Foetal chromosome abnormality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypospadias</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Mosaicism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Patent ductus arteriosus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Polydactyly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Trisomy 13</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Trisomy 15</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Trisomy 17</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Trisomy 21</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Trisomy 22</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Trisomy 9</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Turner's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death neonatal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute fatty liver of pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cervical incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Foetal death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Foetal growth restriction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gestational hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Heterotopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperemesis gravidarum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Postpartum haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Premature baby</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Premature labour</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Premature rupture of membranes</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Prolonged labour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Transverse presentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Umbilical cord abnormality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vanishing twin syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian hyperstimulation syndrome</sub_title>
                <description>Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="403" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="391" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="69" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="66" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Localised intraabdominal fluid collection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Crying</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="82" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site scab</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site vesicles</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Infected bites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post procedural discomfort</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Procedural hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood oestrogen increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Infertility tests</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="145" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="127" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Retinal migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion early</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cervical incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gestational diabetes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemorrhage in pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperemesis gravidarum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Placenta praevia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Premature rupture of membranes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Retained placenta or membranes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Subchorionic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Subchorionic haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vanishing twin syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vomiting in pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Emotional disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adnexa uteri pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cervical discharge</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cervical polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Coital bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fallopian tube cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypomenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ovarian enlargement</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ovarian hyperstimulation syndrome</sub_title>
                <description>Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.</description>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pelvic discomfort</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine cervix stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine spasm</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginal odour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vulvovaginal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinus operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine dilation and curettage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Diastolic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="549"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="551"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="24"/>
              </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>Contract agreement. Results may not be published or referred to, in whole or in part, without the prior express written consent of the Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Executive VP of Regulatory Affairs</name_or_title>
      <organization>Fertility Biotech AG</organization>
      <email>maria.vazquez@fertilitybiotech.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/NCT01687712
org study id: FIN3002
nct id: NCT01687712
lead sponsor: 
has dmc: No
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle
      stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f®
      RFF.
Comparison of the clinical pregnancy rate in the AFOLIA group compared to the US approved
      Gonal-f® RFF Redi-ject group as the primary endpoint. Comparison of the number and size of
      follicles, the number of cycle cancellation, the hormone parameters and adverse events in the
      AFOLIA group compared to the Gonal-f® RFF group as secondary endpoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population
time frame: Six weeks post embryo transfer
description: Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.
measure: Clinical Pregnancy Rate After One Cycle of Treatment - PP Population
time frame: Six weeks post embryo transfer
description: Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.
measure: Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1
time frame: Measured at discretionary visits between Days 9 and 15 after FSH starts
description: The number of days of r-hFSH stimulation a subject received during Cycle 1.
measure: Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1
time frame: Measured at discretionary visits between Days 9 and 15 after FSH starts.
description: The total dose of r-hFSH that subjects received during Cycle 1.
measure: Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1
time frame: Measured at discretionary visits between Days 9 and 15 after FSH starts.
description: The mean dose of r-hFSH that subjects received in a day during Cycle 1.
measure: Number of Oocytes Retrieved - Cycle 1
time frame: Visit 8, 34-36 hours after hCG administration
description: The number of oocytes retrieved per subject, following hCG administration in Cycle 1.
measure: Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1
time frame: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).
description: Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.
measure: Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1
time frame: Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).
description: Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction
measure: Overall Summary of Adverse Events (AEs) - Cycle 1
time frame: Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).
description: Summary of AEs, including the number of subjects experiencing to following during Cycle 1:
At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication
measure: Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1
time frame: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
description: Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
measure: Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2
time frame: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
description: Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
measure: Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3
time frame: Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).
description: Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.
measure: Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1
time frame: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
description: Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.
measure: Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2
time frame: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
description: Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.
measure: Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3
time frame: Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).
description: Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.
arm group label: AFOLIA
arm group type: Experimental
description: One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
arm group label: Gonal-f® RFF
arm group type: Active Comparator
description: One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
intervention type: Drug
intervention name: AFOLIA
description: 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
arm group label: AFOLIA
other name: Follitropin-alfa
intervention type: Drug
intervention name: Gonal-f® RFF
description: 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
arm group label: Gonal-f® RFF
other name: Follitropin-alfa
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 42 Years
healthy volunteers: No
last name: Julian Jenkins, DM FRCOG
role: Study Director
affiliation: Fertility Biotech AG
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country: United States
responsible party type: Sponsor
mesh term: Infertility
mesh term: Follicle Stimulating Hormone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 