<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/NCT03228394</url>
  </required_header>
  <id_info>
    <org_study_id>1042-PPD-2002</org_study_id>
    <nct_id>NCT03228394</nct_id>
  </id_info>
  <brief_title>A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression</brief_title>
  <official_title>A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marinus Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marinus Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of&#xD;
      Ganaxolone in Women with Postpartum Depression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will explore whether ganaxolone is safe and well tolerated in women suffering from&#xD;
      PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed&#xD;
      through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through&#xD;
      pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and&#xD;
      dosing regimen for further development in PPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Actual">May 10, 2020</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score</measure>
    <time_frame>Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6</time_frame>
    <description>The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HAMD17 Total Score at Indicated Time Points</measure>
    <time_frame>Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71</time_frame>
    <description>The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HAMD17 Response</measure>
    <time_frame>Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71</time_frame>
    <description>HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 response is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HAMD17 Remission</measure>
    <time_frame>Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71</time_frame>
    <description>HAMD17 Remission was defined as total score ≤7. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 remission is presented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score</measure>
    <time_frame>Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71</time_frame>
    <description>The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, &amp; 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score</measure>
    <time_frame>Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71</time_frame>
    <description>The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. &quot;I feel calm&quot;; 2. &quot;I am tense&quot;; 3. &quot;I feel upset&quot;; 4. &quot;I am relaxed&quot;; 5. &quot;I feel content&quot;; 6. &quot;I am worried&quot;. Each of these questions were rated as: a) &quot;not at all&quot;; b) &quot;somewhat&quot;; c) &quot;moderately&quot;; d) &quot;very much&quot;. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale</measure>
    <time_frame>Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71</time_frame>
    <description>The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. &quot;very much improved&quot;; 2. &quot;much improved&quot;; 3. &quot;minimally improved&quot;; 4. &quot;no change&quot;; 5. &quot;minimally worse&quot;; 6. &quot;much worse&quot;; 7. &quot;very much worse&quot;. Higher scores indicated worse condition. Response was defined as &gt;50% decrease from Baseline in CGI-I total score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Depression</condition>
  <condition>Depressive Disorder</condition>
  <condition>Depression, Postpartum</condition>
  <condition>Behavioral Symptoms</condition>
  <condition>Mood Disorders</condition>
  <condition>Mental Disorders</condition>
  <condition>Puerperal Disorders</condition>
  <condition>Pregnancy Complications</condition>
  <condition>Postpartum</condition>
  <condition>PPD</condition>
  <arm_group>
    <arm_group_label>Ganaxolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ganaxolone</intervention_name>
    <description>Ganaxolone IV</description>
    <arm_group_label>Ganaxolone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo IV</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant experienced a Major Depressive Episode, which started between the start of&#xD;
             the third trimester and 4 weeks following delivery. The Major Depressive Episode must&#xD;
             be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0&#xD;
             interview&#xD;
&#xD;
          -  Participant gave birth in the last 6 months&#xD;
&#xD;
          -  Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥&#xD;
             26 at screening&#xD;
&#xD;
          -  Participant must agree to stop breastfeeding from start of study treatment or must&#xD;
             agree to temporarily cease giving breast milk to her infant(s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past history of any psychotic illness, including Major Depressive Episode&#xD;
             with psychotic features&#xD;
&#xD;
          -  History of suicide attempt within the past 3 years&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  History of bipolar I disorder&#xD;
&#xD;
          -  History of seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with postpartum depression</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>66206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marinus Research Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>May 24, 2022</results_first_submitted>
  <results_first_submitted_qc>January 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <disposition_first_submitted>September 2, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>January 13, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 8, 2023</disposition_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postpartum Care</keyword>
  <keyword>Postpartum Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Puerperal Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Behavioral Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganaxolone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03228394/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03228394/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Cohort 1</title>
          <description>Intravenous (IV) infusion of placebo (PBO) at rate of 16 milliliter per hour (mL/h) for 48 hours, then 8 mL/h for 12 hours</description>
        </group>
        <group group_id="P2">
          <title>Ganaxolone Cohort 1</title>
          <description>IV infusion of ganaxolone (GNX) at rate of 4 milligram per hour (mg/h) (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
        </group>
        <group group_id="P3">
          <title>Placebo Cohort 2</title>
          <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours.</description>
        </group>
        <group group_id="P4">
          <title>Ganaxolone Cohort 2</title>
          <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
        </group>
        <group group_id="P5">
          <title>Placebo Cohort 3</title>
          <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL for 48 hours and then 12 mL/h for 12 hours.</description>
        </group>
        <group group_id="P6">
          <title>Ganaxolone Cohort 3</title>
          <description>IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours.</description>
        </group>
        <group group_id="P7">
          <title>Placebo Cohort 6</title>
          <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
        </group>
        <group group_id="P8">
          <title>Ganaxolone Cohort 6</title>
          <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo Cohort 1</title>
          <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
        </group>
        <group group_id="B2">
          <title>Ganaxolone Cohort 1</title>
          <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
        </group>
        <group group_id="B3">
          <title>Placebo Cohort 2</title>
          <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
        </group>
        <group group_id="B4">
          <title>Ganaxolone Cohort 2</title>
          <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
        </group>
        <group group_id="B5">
          <title>Placebo Cohort 3</title>
          <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
        </group>
        <group group_id="B6">
          <title>Ganaxolone Cohort 3</title>
          <description>IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours</description>
        </group>
        <group group_id="B7">
          <title>Placebo Cohort 6</title>
          <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
        </group>
        <group group_id="B8">
          <title>Ganaxolone Cohort 6</title>
          <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
        </group>
        <group group_id="B9">
          <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="4"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="10"/>
            <count group_id="B7" value="17"/>
            <count group_id="B8" value="16"/>
            <count group_id="B9" value="91"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.3" spread="2.22"/>
                    <measurement group_id="B2" value="24.4" spread="6.27"/>
                    <measurement group_id="B3" value="26.4" spread="6.02"/>
                    <measurement group_id="B4" value="27.0" spread="7.11"/>
                    <measurement group_id="B5" value="26.4" spread="5.70"/>
                    <measurement group_id="B6" value="25.0" spread="4.11"/>
                    <measurement group_id="B7" value="24.9" spread="5.10"/>
                    <measurement group_id="B8" value="28.8" spread="4.97"/>
                    <measurement group_id="B9" value="26.30" spread="3.495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="30"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score</title>
        <description>The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6</time_frame>
        <population>Modified intent-to-treat (mITT) population: Included all participants in the safety set who had ≥1 post-randomization efficacy assessment. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score</title>
          <description>The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>Modified intent-to-treat (mITT) population: Included all participants in the safety set who had ≥1 post-randomization efficacy assessment. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="14"/>
                <count group_id="O8" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.0" spread="10.10"/>
                    <measurement group_id="O2" value="-12.0" spread="6.82"/>
                    <measurement group_id="O3" value="-14.0" spread="9.10"/>
                    <measurement group_id="O4" value="-14.3" spread="10.23"/>
                    <measurement group_id="O5" value="-11.0" spread="6.58"/>
                    <measurement group_id="O6" value="-11.3" spread="7.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-13.6" spread="11.51"/>
                    <measurement group_id="O8" value="-11.5" spread="11.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HAMD17 Total Score at Indicated Time Points</title>
        <description>The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71</time_frame>
        <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HAMD17 Total Score at Indicated Time Points</title>
          <description>The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 post-infusion (6 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-3.2" spread="6.85"/>
                    <measurement group_id="O8" value="-6.1" spread="9.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (12 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="7.18"/>
                    <measurement group_id="O2" value="-2.4" spread="1.52"/>
                    <measurement group_id="O3" value="-3.2" spread="6.44"/>
                    <measurement group_id="O4" value="-2.7" spread="5.59"/>
                    <measurement group_id="O5" value="-1.9" spread="4.20"/>
                    <measurement group_id="O6" value="0.3" spread="2.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 (24 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" spread="9.80"/>
                    <measurement group_id="O2" value="-3.8" spread="5.31"/>
                    <measurement group_id="O3" value="-6.4" spread="7.33"/>
                    <measurement group_id="O4" value="-10.1" spread="8.90"/>
                    <measurement group_id="O5" value="-5.2" spread="7.89"/>
                    <measurement group_id="O6" value="-3.4" spread="4.13"/>
                    <measurement group_id="O7" value="-5.1" spread="5.07"/>
                    <measurement group_id="O8" value="-7.8" spread="8.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (48 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.8" spread="12.09"/>
                    <measurement group_id="O2" value="-11.0" spread="3.67"/>
                    <measurement group_id="O3" value="-10.5" spread="9.26"/>
                    <measurement group_id="O4" value="-13.7" spread="11.68"/>
                    <measurement group_id="O5" value="-8.7" spread="7.15"/>
                    <measurement group_id="O6" value="-11.2" spread="4.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (72 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.8" spread="14.73"/>
                    <measurement group_id="O2" value="-10.2" spread="10.06"/>
                    <measurement group_id="O3" value="-14.5" spread="9.12"/>
                    <measurement group_id="O4" value="-17.3" spread="9.22"/>
                    <measurement group_id="O5" value="-14.0" spread="6.72"/>
                    <measurement group_id="O6" value="-10.5" spread="8.57"/>
                    <measurement group_id="O7" value="-7.8" spread="6.83"/>
                    <measurement group_id="O8" value="-7.0" spread="6.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-8.7" spread="8.99"/>
                    <measurement group_id="O8" value="-8.7" spread="9.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.3" spread="11.79"/>
                    <measurement group_id="O2" value="-6.2" spread="5.72"/>
                    <measurement group_id="O3" value="-9.7" spread="9.67"/>
                    <measurement group_id="O4" value="-14.0" spread="12.56"/>
                    <measurement group_id="O5" value="-8.2" spread="7.80"/>
                    <measurement group_id="O6" value="-8.9" spread="9.65"/>
                    <measurement group_id="O7" value="-13.6" spread="7.58"/>
                    <measurement group_id="O8" value="-13.6" spread="9.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-11.6" spread="8.38"/>
                    <measurement group_id="O8" value="-12.7" spread="9.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-12.3" spread="10.50"/>
                    <measurement group_id="O8" value="-12.7" spread="9.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" spread="12.46"/>
                    <measurement group_id="O2" value="-11.0" spread="9.62"/>
                    <measurement group_id="O3" value="-13.3" spread="6.48"/>
                    <measurement group_id="O4" value="-16.5" spread="10.10"/>
                    <measurement group_id="O5" value="-9.1" spread="8.70"/>
                    <measurement group_id="O6" value="-11.1" spread="12.25"/>
                    <measurement group_id="O7" value="-13.5" spread="10.76"/>
                    <measurement group_id="O8" value="-13.0" spread="10.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-16.0" spread="9.70"/>
                    <measurement group_id="O8" value="-12.0" spread="9.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-19.0" spread="7.87"/>
                    <measurement group_id="O8" value="-14.8" spread="11.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HAMD17 Response</title>
        <description>HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 response is presented.</description>
        <time_frame>Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71</time_frame>
        <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HAMD17 Response</title>
          <description>HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 response is presented.</description>
          <population>mITT population. Only those participants with data available at the specified data points were analyzed.</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="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 post-infusion (6 hours post start of infusion): Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (12 hours post start of infusion): Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" 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 group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 (24 hours post start of infusion): Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (48 hours post start of infusion): Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion): Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (72 hours post start of infusion): Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Responder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HAMD17 Remission</title>
        <description>HAMD17 Remission was defined as total score ≤7. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 remission is presented</description>
        <time_frame>Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71</time_frame>
        <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HAMD17 Remission</title>
          <description>HAMD17 Remission was defined as total score ≤7. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 remission is presented</description>
          <population>mITT population. Only those participants with data available at the specified data points were analyzed.</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="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 post-infusion (6 hours post start of infusion): Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (12 hours post start of infusion): Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" 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 group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 (24 hours post start of infusion): Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (48 hours post start of infusion): Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion): Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (72 hours post start of infusion): Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score</title>
        <description>The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, &amp; 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71</time_frame>
        <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score</title>
          <description>The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, &amp; 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-1.9" spread="2.87"/>
                    <measurement group_id="O8" value="-5.4" spread="6.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-4.9" spread="4.76"/>
                    <measurement group_id="O8" value="-7.5" spread="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.8" spread="14.64"/>
                    <measurement group_id="O2" value="-8.0" spread="8.63"/>
                    <measurement group_id="O3" value="-10.8" spread="6.66"/>
                    <measurement group_id="O4" value="-10.8" spread="6.32"/>
                    <measurement group_id="O5" value="-12.2" spread="6.21"/>
                    <measurement group_id="O6" value="-10.9" spread="6.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-6.7" spread="6.01"/>
                    <measurement group_id="O8" value="-9.6" spread="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.5" spread="11.47"/>
                    <measurement group_id="O2" value="-8.0" spread="4.12"/>
                    <measurement group_id="O3" value="-9.6" spread="6.99"/>
                    <measurement group_id="O4" value="-11.5" spread="8.02"/>
                    <measurement group_id="O5" value="-8.8" spread="6.63"/>
                    <measurement group_id="O6" value="-8.2" spread="7.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-8.0" spread="6.02"/>
                    <measurement group_id="O8" value="-11.3" spread="5.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-8.2" spread="7.37"/>
                    <measurement group_id="O8" value="-11.2" spread="6.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-10.9" spread="8.14"/>
                    <measurement group_id="O8" value="-10.0" spread="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.5" spread="10.08"/>
                    <measurement group_id="O2" value="-8.6" spread="5.32"/>
                    <measurement group_id="O3" value="-9.8" spread="5.83"/>
                    <measurement group_id="O4" value="-13.4" spread="5.81"/>
                    <measurement group_id="O5" value="-9.1" spread="5.88"/>
                    <measurement group_id="O6" value="-8.8" spread="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-11.8" spread="6.57"/>
                    <measurement group_id="O8" value="-12.4" spread="6.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-11.8" spread="6.79"/>
                    <measurement group_id="O8" value="-9.4" spread="8.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-14.0" spread="5.62"/>
                    <measurement group_id="O8" value="-11.5" spread="7.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score</title>
        <description>The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. &quot;I feel calm&quot;; 2. &quot;I am tense&quot;; 3. &quot;I feel upset&quot;; 4. &quot;I am relaxed&quot;; 5. &quot;I feel content&quot;; 6. &quot;I am worried&quot;. Each of these questions were rated as: a) &quot;not at all&quot;; b) &quot;somewhat&quot;; c) &quot;moderately&quot;; d) &quot;very much&quot;. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71</time_frame>
        <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score</title>
          <description>The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. &quot;I feel calm&quot;; 2. &quot;I am tense&quot;; 3. &quot;I feel upset&quot;; 4. &quot;I am relaxed&quot;; 5. &quot;I feel content&quot;; 6. &quot;I am worried&quot;. Each of these questions were rated as: a) &quot;not at all&quot;; b) &quot;somewhat&quot;; c) &quot;moderately&quot;; d) &quot;very much&quot;. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (12 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.9" spread="20.09"/>
                    <measurement group_id="O2" value="-4.2" spread="13.44"/>
                    <measurement group_id="O3" value="-14.5" spread="14.48"/>
                    <measurement group_id="O4" value="-12.01" spread="11.25"/>
                    <measurement group_id="O5" value="-10.7" spread="10.52"/>
                    <measurement group_id="O6" value="-11.3" spread="19.51"/>
                    <measurement group_id="O7" value="-9.4" spread="14.78"/>
                    <measurement group_id="O8" value="-17.7" spread="20.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.2" spread="15.00"/>
                    <measurement group_id="O2" value="-8.7" spread="13.25"/>
                    <measurement group_id="O3" value="-15.0" spread="11.23"/>
                    <measurement group_id="O4" value="-14.2" spread="17.88"/>
                    <measurement group_id="O5" value="-12.7" spread="10.04"/>
                    <measurement group_id="O6" value="-12.0" spread="13.07"/>
                    <measurement group_id="O7" value="-12.9" spread="11.42"/>
                    <measurement group_id="O8" value="-19.0" spread="17.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" spread="33.39"/>
                    <measurement group_id="O2" value="-22.0" spread="18.65"/>
                    <measurement group_id="O3" value="-18.2" spread="12.95"/>
                    <measurement group_id="O4" value="-21.0" spread="16.46"/>
                    <measurement group_id="O5" value="-24.3" spread="16.11"/>
                    <measurement group_id="O6" value="-24.0" spread="15.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.0" spread="23.73"/>
                    <measurement group_id="O2" value="-20.7" spread="19.78"/>
                    <measurement group_id="O3" value="-21.0" spread="13.77"/>
                    <measurement group_id="O4" value="-22.9" spread="17.14"/>
                    <measurement group_id="O5" value="-25.0" spread="13.99"/>
                    <measurement group_id="O6" value="-22.3" spread="17.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-10.2" spread="18.88"/>
                    <measurement group_id="O8" value="-15.6" spread="15.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.7" spread="25.17"/>
                    <measurement group_id="O2" value="-18.7" spread="20.22"/>
                    <measurement group_id="O3" value="-16.9" spread="13.06"/>
                    <measurement group_id="O4" value="-20.8" spread="17.17"/>
                    <measurement group_id="O5" value="-17.0" spread="16.74"/>
                    <measurement group_id="O6" value="-16.0" spread="15.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-12.3" spread="20.39"/>
                    <measurement group_id="O8" value="-17.4" spread="19.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-15.9" spread="15.88"/>
                    <measurement group_id="O8" value="-21.8" spread="16.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-20.8" spread="13.89"/>
                    <measurement group_id="O8" value="-18.9" spread="18.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.8" spread="27.54"/>
                    <measurement group_id="O2" value="-16.0" spread="21.53"/>
                    <measurement group_id="O3" value="-16.1" spread="13.55"/>
                    <measurement group_id="O4" value="-24.4" spread="13.80"/>
                    <measurement group_id="O5" value="-18.7" spread="13.90"/>
                    <measurement group_id="O6" value="-17.7" spread="20.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-21.9" spread="9.69"/>
                    <measurement group_id="O8" value="-21.7" spread="19.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-21.7" spread="12.67"/>
                    <measurement group_id="O8" value="-13.3" spread="25.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-31.7" spread="16.97"/>
                    <measurement group_id="O8" value="-21.0" spread="16.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale</title>
        <description>The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. &quot;very much improved&quot;; 2. &quot;much improved&quot;; 3. &quot;minimally improved&quot;; 4. &quot;no change&quot;; 5. &quot;minimally worse&quot;; 6. &quot;much worse&quot;; 7. &quot;very much worse&quot;. Higher scores indicated worse condition. Response was defined as &gt;50% decrease from Baseline in CGI-I total score.</description>
        <time_frame>Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71</time_frame>
        <population>mITT population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Cohort 1</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O2">
            <title>Ganaxolone Cohort 1</title>
            <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
          </group>
          <group group_id="O3">
            <title>Placebo Cohort 2</title>
            <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
          </group>
          <group group_id="O4">
            <title>Ganaxolone Cohort 2</title>
            <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
          </group>
          <group group_id="O5">
            <title>Placebo Cohort 3</title>
            <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
          </group>
          <group group_id="O6">
            <title>Ganaxolone Cohort 3</title>
            <description>IV bolus of GNX 12 mg (24mL) over 2 min; then 12 mg/h (24mL/h) for 48hrs.</description>
          </group>
          <group group_id="O7">
            <title>Placebo Cohort 6</title>
            <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
          </group>
          <group group_id="O8">
            <title>Ganaxolone Cohort 6</title>
            <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale</title>
          <description>The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. &quot;very much improved&quot;; 2. &quot;much improved&quot;; 3. &quot;minimally improved&quot;; 4. &quot;no change&quot;; 5. &quot;minimally worse&quot;; 6. &quot;much worse&quot;; 7. &quot;very much worse&quot;. Higher scores indicated worse condition. Response was defined as &gt;50% decrease from Baseline in CGI-I total score.</description>
          <population>mITT population. Only those participants with data available at the specified data points were analyzed.</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="4"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (12 hours post start of infusion): Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (12 hours post start of infusion): Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="10"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion): Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 post-infusion (60 hours post start of infusion): Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 34: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Very much or much improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 71: Minimally or not improved</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 71 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Cohort 1</title>
          <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
        </group>
        <group group_id="E2">
          <title>Ganaxolone Cohort 1</title>
          <description>IV infusion of GNX at rate of 4 mg/h (16 mL/h) for 48 hours, then 2 mg/h for 12 hours</description>
        </group>
        <group group_id="E3">
          <title>Placebo Cohort 2</title>
          <description>IV infusion of PBO at rate of 16 mL/h for 48 hours, then 8 mL/h for 12 hours</description>
        </group>
        <group group_id="E4">
          <title>Ganaxolone Cohort 2</title>
          <description>IV infusion of GNX at rate of 8 mg/h for 48 hours, then 4 mg/h (8 mL/h) for 12 hours</description>
        </group>
        <group group_id="E5">
          <title>Placebo Cohort 3</title>
          <description>IV bolus of 24 mL PBO over 2 minutes; then 24 mL/h for 48 hours and then 12 mL/h for 12 hours</description>
        </group>
        <group group_id="E6">
          <title>Ganaxolone Cohort 3</title>
          <description>IV bolus of 12 mg (24mL) GNX over 2 minutes; then GNX at 12 mg/h (24 mL/h) for 48 hours and then 6 mg/h (12 mL/h) for 12 hours</description>
        </group>
        <group group_id="E7">
          <title>Placebo Cohort 6</title>
          <description>IV infusion of PBO at rate of 40 mL/h for 6 hours; then 900 mg PBO (4 capsules) orally at dinner for 28 days</description>
        </group>
        <group group_id="E8">
          <title>Ganaxolone Cohort 6</title>
          <description>IV infusion of GNX at rate of 20 mg/h (40 mL/h) for 6 hours followed by 900 mg (4 capsules) orally at dinner for 28 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Feeling Hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Feeling of Relaxation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Infusion Site Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Infusion Site Irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Infusion Site Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Infusion Site Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mastitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Blood Thyroid Stimulating Hormone Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Coordination Abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="8" subjects_affected="4" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Psychomotor Hyperactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Euphoric Mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Thinking Abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Eccymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pruritus Generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Rash Papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marinus Clinical Trials Submission Manager</name_or_title>
      <organization>Marinus Pharmaceuticals, Inc.</organization>
      <phone>484-801-4670</phone>
      <email>clinicaltrials@marinuspharma.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/NCT03228394
org study id: 1042-PPD-2002
nct id: NCT03228394
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of
      Ganaxolone in Women with Postpartum Depression
This study will explore whether ganaxolone is safe and well tolerated in women suffering from
      PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed
      through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through
      pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and
      dosing regimen for further development in PPD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score
time frame: Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6
description: The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Change From Baseline in HAMD17 Total Score at Indicated Time Points
time frame: Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71
description: The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Number of Participants With HAMD17 Response
time frame: Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71
description: HAMD17 Response was defined as ≥50% reduction from Baseline in total score. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 response is presented.
measure: Number of Participants With HAMD17 Remission
time frame: Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71
description: HAMD17 Remission was defined as total score ≤7. The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. Number of participants with HAMD17 remission is presented
measure: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
time frame: Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71
description: The EPDS is a validated 10-question depression assessment for postpartum women, which includes anxiety symptoms and excludes constitutional symptoms associated with depression common in the postpartum period, such as changes in sleeping patterns. It consists of 10 multiple choice questions with scores for each question ranging from 0-3. Questions 1, 2, & 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3 and 5 to 10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Scores are then summed for a total score, which ranges from 0: no depression to 30: severe depression. Higher score indicates severe depression. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score
time frame: Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71
description: The STAI6 is a 6-item self-rated instrument used to assess anxiety state. The STAI6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. The STAI6 score was the result of first totaling the 6 individual item scores, and then prorating by a multiplication factor of 20/6 to acquire a score range of 20 (low anxiety) to 80 (high anxiety). Higher score indicated higher level of anxiety. Baseline was defined as the Day 1 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale
time frame: Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71
description: The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. Response was defined as >50% decrease from Baseline in CGI-I total score.
arm group label: Ganaxolone
arm group type: Experimental
description: Intravenous
arm group label: Placebo
arm group type: Placebo Comparator
description: Intravenous
intervention type: Drug
intervention name: Ganaxolone
description: Ganaxolone IV
arm group label: Ganaxolone
intervention type: Drug
intervention name: Placebo
description: Placebo IV
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: Women with postpartum depression
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Pregnancy Complications
mesh term: Puerperal Disorders
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Mental Disorders
mesh term: Mood Disorders
mesh term: Behavioral Symptoms
mesh term: Ganaxolone
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