<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/NCT01725308</url>
  </required_header>
  <id_info>
    <org_study_id>6949-CL-0021</org_study_id>
    <nct_id>NCT01725308</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes</brief_title>
  <official_title>Phase II/III Study of FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study in Bipolar Disorder Patients With Major Depressive Episodes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In period I, the treatment effect of FK949E was compared with that of placebo in a blind&#xD;
      manner in bipolar disorder patients with major depressive episodes. In period II, the&#xD;
      long-term safety and efficacy of FK949E was evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consisted of two parts. In Treatment Period I, FK949E or placebo was administered&#xD;
      orally in a blind manner to bipolar disorder patients with major depressive episodes, with&#xD;
      the aim of evaluating the superiority of FK949E over placebo and the dose response of two&#xD;
      doses of FK949E based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) total&#xD;
      score. In Treatment Period II, the long-term safety, efficacy and pharmacokinetics of&#xD;
      open-label FK949E was evaluated in patients who completed Treatment Period I. An analysis was&#xD;
      performed for data in Treatment Period I and another analysis was done for data in combined&#xD;
      Treatment Periods I and II.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2012</start_date>
  <completion_date type="Actual">July 11, 2016</completion_date>
  <primary_completion_date type="Actual">August 1, 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in MADRS Total Score (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With MADRS Response (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With MADRS Response (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With MADRS Remission (Treatment Period I)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With MADRS Remission (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HAM-D17 (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52</time_frame>
    <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HAM-D17 Response (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52</time_frame>
    <description>A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CGI-BP-S: Depression (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-BP-C: Mania (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 1)</time_frame>
    <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-BP-C: Depression (Treatment Period I)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-BP-C: Depression (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 1)</time_frame>
    <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-BP-C: Overall Bipolar Illness (Treatment Period I)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 1)</time_frame>
    <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (Treatment Period I)</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (Combined Treatment Period I and II)</measure>
    <time_frame>Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E &amp; FK949E 300 mg / FK949E groups, from week 0 to week 52)</time_frame>
    <description>An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 4, 8</time_frame>
    <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52</time_frame>
    <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 4, 8</time_frame>
    <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52</time_frame>
    <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)</measure>
    <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
    <description>The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates &quot;Absent&quot; or &quot;Normal.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in YMRS (Combined Treatment Period I and II)</measure>
    <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
    <description>The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates &quot;Absent&quot; or &quot;Normal.&quot; Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)</measure>
    <time_frame>Weeks 4, 8</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)</measure>
    <time_frame>Weeks 4, 8</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)</measure>
    <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
    <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">431</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FK949E 150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FK949E 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo / FK949E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FK949E 150 mg / FK949E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FK949E 300 mg / FK949E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FK949E</intervention_name>
    <description>Taken by mouth (orally).</description>
    <arm_group_label>FK949E 150 mg</arm_group_label>
    <arm_group_label>FK949E 150 mg / FK949E</arm_group_label>
    <arm_group_label>FK949E 300 mg</arm_group_label>
    <arm_group_label>FK949E 300 mg / FK949E</arm_group_label>
    <arm_group_label>Placebo / FK949E</arm_group_label>
    <other_name>quetiapine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Taken by mouth (orally).</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Placebo / FK949E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of bipolar I or II disorder as specified in the Diagnostic and Statistical&#xD;
             Manual of Mental Disorders Ver. 4 Text Revision (DSM-IV-TR,) with a major depressive&#xD;
             episode&#xD;
&#xD;
          -  The Hamilton Depression Rating Scale (HAM-D17) total score of 20 points or more and&#xD;
             HAM-D17 depressed mood score of 2 points or more&#xD;
&#xD;
          -  Able to participate in the study with understanding of and compliance with subject&#xD;
             requirements during the study in the investigator's or subinvestigator's opinion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder,&#xD;
             within the last 6 months before informed consent&#xD;
&#xD;
          -  Concurrence of DSM-IV-TR Axis II disorder that is considered to greatly affect&#xD;
             patient's current mental status&#xD;
&#xD;
          -  The Young Mania Rating Scale (YMRS) total score of 13 points or more&#xD;
&#xD;
          -  Nine or more mood episodes within the last 12 months before informed consent&#xD;
&#xD;
          -  Lack of response to at least 6-week treatment with at least 2 antidepressants for the&#xD;
             current major depressive episode in the investigator's or subinvestigator's opinion&#xD;
&#xD;
          -  History of abuse or dependence of alcohol or substances other than caffeine and&#xD;
             nicotine&#xD;
&#xD;
          -  Treatment with a depot antipsychotic within the last 42 days before primary&#xD;
             registration&#xD;
&#xD;
          -  Unable to stop taking mood stabilizers (lithium carbonate and/or sodium valproate),&#xD;
             lamotrigine, antipsychotics, or antidepressants from 7 days before secondary&#xD;
             registration&#xD;
&#xD;
          -  Unable to stop taking antiepileptics (except lamotrigine and sodium valproate),&#xD;
             antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents,&#xD;
             cerebral ameliorators, antidementia agents, or anorectics, except those specified as&#xD;
             conditionally-allowed concomitant drugs, after primary registration&#xD;
&#xD;
          -  Electroconvulsive therapy within the last 76 days before primary registration&#xD;
&#xD;
          -  The current major depressive episode persisting for more than 12 months or less than 4&#xD;
             weeks before informed consent&#xD;
&#xD;
          -  A possible need of psychotherapy during the study period (unless the therapy has been&#xD;
             commenced at least 76 days before primary registration and been maintained on a fixed&#xD;
             level at fixed frequency)&#xD;
&#xD;
          -  Documented or suspected conditions such as renal failure, hepatic failure, serious&#xD;
             cardiac disease, hepatitis B, hepatitis C, or acquired immunodeficiency syndrome&#xD;
             (AIDS) (or to be a carrier of hepatitis B, hepatitis C, or AIDS)&#xD;
&#xD;
          -  Concurrence of malignancy or history of cured malignancy within 5 years&#xD;
&#xD;
          -  Concurrence of uncontrolled hypertension (defined as a systolic blood pressure of 180&#xD;
             mmHg or more, or a diastolic blood pressure of 110 mmHg or more at primary&#xD;
             registration) or unstable angina that may worsen with the study or may affect the&#xD;
             study results based on the clinical judgment of the investigator or sub-investigator&#xD;
&#xD;
          -  Concurrence of hypotension (defined as a systolic blood pressure of less than 100 mmHg&#xD;
             at primary registration) or orthostatic hypotension&#xD;
&#xD;
          -  History of transient, idiopathic orthostatic hypotension, with or without pre-syncope&#xD;
             symptoms or syncope, or a current condition susceptible to transient hypotension, such&#xD;
             as dehydration and decreased blood volume&#xD;
&#xD;
          -  Concurrent or previous history of cerebrovascular disease or transient ischemic attack&#xD;
             (TIA)&#xD;
&#xD;
          -  Abnormal laboratory or electrocardiographic findings considered clinically significant&#xD;
             in the investigator's or subinvestigator's opinion (in reference to grade 3 of the&#xD;
             Adverse Drug Reactions Severity Grading Criteria [Notification No. 80 of the Safety&#xD;
             Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare dated 29 June&#xD;
             1992])&#xD;
&#xD;
          -  Participation in another clinical study or post-marketing study within the last 12&#xD;
             weeks before informed consent&#xD;
&#xD;
          -  History of quetiapine therapy during the current major depressive episode&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site JP00030</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00031</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00052</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00055</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00072</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00092</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00003</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00008</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00009</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00002</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00037</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00038</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00039</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00040</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00041</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00058</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00082</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00083</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00091</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00094</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00095</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00096</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00097</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00098</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00004</name>
      <address>
        <city>Fukushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00028</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00006</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00007</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00035</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00056</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00067</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00001</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00059</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00061</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00062</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00068</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00069</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00073</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00074</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00076</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00005</name>
      <address>
        <city>Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00049</name>
      <address>
        <city>Kagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00021</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00022</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00023</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00024</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00025</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00042</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00050</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00032</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00084</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00077</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00027</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00075</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00053</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00054</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00079</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00043</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00046</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00033</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00034</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00047</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00063</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00029</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00036</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00010</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00011</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00012</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00013</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00014</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00015</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00016</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00017</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00018</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00019</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00020</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00045</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00048</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00051</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00057</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00060</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00064</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00065</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00066</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00070</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00071</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00078</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00081</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00085</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00086</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00087</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00088</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00089</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00090</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00093</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00099</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00044</name>
      <address>
        <city>Tottori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00026</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.astellasclinicalstudyresults.com/study.aspx?ID=221</url>
    <description>Link to results on Astellas Clinical Study Results website</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <results_first_submitted>December 16, 2016</results_first_submitted>
  <results_first_submitted_qc>December 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 8, 2017</results_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FK949E</keyword>
  <keyword>Major depressive episode</keyword>
  <keyword>patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quetiapine Fumarate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Japanese patients with bipolar I or bipolar II as specified in Diagnostic and Statistical Manual of Mental Disorders Ver. 4 Text Revision (DSM-IV-TR) whose most recent episode was diagnosed as a major depressive episode using the Mini-International Neuropsychiatric Interview (MINI) were recruited for this study.</recruitment_details>
      <pre_assignment_details>Assignment of participants to the FK949E 150 mg group was discontinued with implementation of Version 3.0 of the protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo / FK949E</title>
          <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="P2">
          <title>FK949E 150 mg / FK949E</title>
          <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="P3">
          <title>FK949E 300 mg / FK949E</title>
          <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period I</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="178"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did Not Receive Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insufficient Response</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Worsening of the Target Disease</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Changes in the Episodes</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of Consent</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviations</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period II</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did Not Meet Transition Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Receive Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insufficient Response</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Worsening of the Target Disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Changes in the Episodes</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of Consent</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviations</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS), which included participants who received at least one dose of study drug and had measurements taken for at least one efficacy endpoint after start of drug treatment in Treatment Period I.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
        </group>
        <group group_id="B2">
          <title>FK949E 150 mg</title>
          <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
        </group>
        <group group_id="B3">
          <title>FK949E 300 mg</title>
          <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="177"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="179"/>
            <count group_id="B4" value="430"/>
          </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="38.8" spread="11.0"/>
                    <measurement group_id="B2" value="39.2" spread="10.2"/>
                    <measurement group_id="B3" value="38.1" spread="11.2"/>
                    <measurement group_id="B4" value="38.6" spread="10.9"/>
                  </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="101"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="231"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="86"/>
                    <measurement group_id="B4" value="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Montgomery-Åsberg Depression Rating Scale (MADRS) score</title>
          <description>The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.8" spread="6.4"/>
                    <measurement group_id="B2" value="30.2" spread="6.8"/>
                    <measurement group_id="B3" value="30.9" spread="6.9"/>
                    <measurement group_id="B4" value="30.7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Hamilton Depression Rating Scale (HAM-D17) Score</title>
          <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.1" spread="2.8"/>
                    <measurement group_id="B2" value="23.3" spread="3.4"/>
                    <measurement group_id="B3" value="23.0" spread="3.0"/>
                    <measurement group_id="B4" value="23.1" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants wirth MADRS Remission</title>
          <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score</title>
        <description>The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
        <time_frame>Baseline and Week 8</time_frame>
        <population>FAS; Last observation carried forward (LOCF) imputation was used for end of Treatment Period I.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score</title>
          <description>The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
          <population>FAS; Last observation carried forward (LOCF) imputation was used for end of Treatment Period I.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="10.9"/>
                    <measurement group_id="O2" value="-14.4" spread="11.4"/>
                    <measurement group_id="O3" value="-12.6" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.034</p_value>
            <method>ANCOVA</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-2.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.7</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in MADRS Total Score (Treatment Period I)</title>
        <description>The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in MADRS Total Score (Treatment Period I)</title>
          <description>The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
          <population>FAS; LOCF imputation was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="5.4"/>
                    <measurement group_id="O2" value="-6.4" spread="8.1"/>
                    <measurement group_id="O3" value="-5.1" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="7.0"/>
                    <measurement group_id="O2" value="-10.0" spread="8.9"/>
                    <measurement group_id="O3" value="-8.3" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="8.8"/>
                    <measurement group_id="O2" value="-11.6" spread="9.9"/>
                    <measurement group_id="O3" value="-9.9" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.5" spread="9.1"/>
                    <measurement group_id="O2" value="-12.5" spread="10.8"/>
                    <measurement group_id="O3" value="-11.8" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.2" spread="10.1"/>
                    <measurement group_id="O2" value="-14.5" spread="11.0"/>
                    <measurement group_id="O3" value="-12.2" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="10.9"/>
                    <measurement group_id="O2" value="-14.4" spread="11.4"/>
                    <measurement group_id="O3" value="-12.6" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)</title>
        <description>The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>FAS for combined Treatment Period I and II, which included participants who received at least one dose of FK949E and had measurements taken for at least one efficacy endpoint after the start of FK949E treatment, and with available data at each time point. LOCF imputation method was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)</title>
          <description>The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS for combined Treatment Period I and II, which included participants who received at least one dose of FK949E and had measurements taken for at least one efficacy endpoint after the start of FK949E treatment, and with available data at each time point. LOCF imputation method was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-6.4" spread="8.1"/>
                    <measurement group_id="O3" value="-5.1" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-10.0" spread="8.9"/>
                    <measurement group_id="O3" value="-8.5" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-12.0" spread="10.1"/>
                    <measurement group_id="O3" value="-10.6" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.1" spread="11.0"/>
                    <measurement group_id="O3" value="-13.2" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-15.6" spread="11.2"/>
                    <measurement group_id="O3" value="-13.8" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-15.8" spread="11.5"/>
                    <measurement group_id="O3" value="-14.8" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-16.3" spread="11.6"/>
                    <measurement group_id="O3" value="-15.9" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-16.4" spread="12.1"/>
                    <measurement group_id="O3" value="-16.0" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="5.8"/>
                    <measurement group_id="O2" value="-18.1" spread="10.4"/>
                    <measurement group_id="O3" value="-13.3" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="7.0"/>
                    <measurement group_id="O2" value="-17.0" spread="10.7"/>
                    <measurement group_id="O3" value="-16.4" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="7.7"/>
                    <measurement group_id="O2" value="-17.1" spread="10.3"/>
                    <measurement group_id="O3" value="-17.2" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="8.0"/>
                    <measurement group_id="O2" value="-17.3" spread="11.5"/>
                    <measurement group_id="O3" value="-19.0" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="8.3"/>
                    <measurement group_id="O2" value="-18.7" spread="10.6"/>
                    <measurement group_id="O3" value="-18.2" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="8.5"/>
                    <measurement group_id="O2" value="-21.4" spread="10.5"/>
                    <measurement group_id="O3" value="-18.4" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="8.6"/>
                    <measurement group_id="O2" value="-22.9" spread="8.5"/>
                    <measurement group_id="O3" value="-19.4" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6" spread="10.2"/>
                    <measurement group_id="O2" value="-22.3" spread="9.6"/>
                    <measurement group_id="O3" value="-19.4" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="9.4"/>
                    <measurement group_id="O2" value="-23.1" spread="10.4"/>
                    <measurement group_id="O3" value="-19.4" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" spread="9.8"/>
                    <measurement group_id="O2" value="-23.3" spread="9.7"/>
                    <measurement group_id="O3" value="-19.8" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.1" spread="10.0"/>
                    <measurement group_id="O2" value="-23.4" spread="10.2"/>
                    <measurement group_id="O3" value="-20.7" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.6" spread="10.0"/>
                    <measurement group_id="O2" value="-24.1" spread="10.2"/>
                    <measurement group_id="O3" value="-20.9" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="10.7"/>
                    <measurement group_id="O2" value="-24.4" spread="10.1"/>
                    <measurement group_id="O3" value="-22.1" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6" spread="10.4"/>
                    <measurement group_id="O2" value="-16.0" spread="13.3"/>
                    <measurement group_id="O3" value="-15.2" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With MADRS Response (Treatment Period I)</title>
        <description>A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MADRS Response (Treatment Period I)</title>
          <description>A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
          <population>FAS; LOCF imputation method was used for all time points.</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="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With MADRS Response (Combined Treatment Period I and II)</title>
        <description>A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MADRS Response (Combined Treatment Period I and II)</title>
          <description>A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With MADRS Remission (Treatment Period I)</title>
        <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MADRS Remission (Treatment Period I)</title>
          <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.</description>
          <population>FAS; LOCF imputation method was used for all time points.</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="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With MADRS Remission (Combined Treatment Period I and II)</title>
        <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MADRS Remission (Combined Treatment Period I and II)</title>
          <description>MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)</title>
        <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)</title>
          <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="4.2"/>
                    <measurement group_id="O2" value="-5.9" spread="5.1"/>
                    <measurement group_id="O3" value="-4.5" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="5.4"/>
                    <measurement group_id="O2" value="-8.7" spread="5.8"/>
                    <measurement group_id="O3" value="-7.0" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6" spread="6.5"/>
                    <measurement group_id="O2" value="-10.0" spread="6.2"/>
                    <measurement group_id="O3" value="-7.9" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" spread="6.7"/>
                    <measurement group_id="O2" value="-10.9" spread="6.6"/>
                    <measurement group_id="O3" value="-9.2" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.7" spread="7.3"/>
                    <measurement group_id="O2" value="-11.9" spread="7.1"/>
                    <measurement group_id="O3" value="-9.6" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="7.6"/>
                    <measurement group_id="O2" value="-11.9" spread="7.4"/>
                    <measurement group_id="O3" value="-10.1" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.033</p_value>
            <method>ANCOVA</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HAM-D17 (Combined Treatment Period I and II)</title>
        <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HAM-D17 (Combined Treatment Period I and II)</title>
          <description>The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-5.9" spread="5.1"/>
                    <measurement group_id="O3" value="-4.5" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-8.8" spread="5.8"/>
                    <measurement group_id="O3" value="-7.1" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-10.3" spread="6.0"/>
                    <measurement group_id="O3" value="-8.4" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-11.4" spread="6.5"/>
                    <measurement group_id="O3" value="-9.9" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-12.7" spread="7.0"/>
                    <measurement group_id="O3" value="-10.7" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.0" spread="7.1"/>
                    <measurement group_id="O3" value="-11.6" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.1" spread="7.8"/>
                    <measurement group_id="O3" value="-12.4" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.7" spread="7.5"/>
                    <measurement group_id="O3" value="-12.6" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="4.7"/>
                    <measurement group_id="O2" value="-13.9" spread="7.5"/>
                    <measurement group_id="O3" value="-12.8" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="5.2"/>
                    <measurement group_id="O2" value="-13.7" spread="7.1"/>
                    <measurement group_id="O3" value="-13.4" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="6.0"/>
                    <measurement group_id="O2" value="-14.6" spread="7.3"/>
                    <measurement group_id="O3" value="-13.8" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="6.0"/>
                    <measurement group_id="O2" value="-16.7" spread="6.4"/>
                    <measurement group_id="O3" value="-14.3" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="6.4"/>
                    <measurement group_id="O2" value="-17.1" spread="6.9"/>
                    <measurement group_id="O3" value="-14.6" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" spread="7.0"/>
                    <measurement group_id="O2" value="-17.0" spread="7.6"/>
                    <measurement group_id="O3" value="-15.1" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.6" spread="7.1"/>
                    <measurement group_id="O2" value="-17.8" spread="7.9"/>
                    <measurement group_id="O3" value="-16.2" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.6" spread="6.6"/>
                    <measurement group_id="O2" value="-12.9" spread="8.7"/>
                    <measurement group_id="O3" value="-11.6" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HAM-D17 Response (Treatment Period I)</title>
        <description>A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HAM-D17 Response (Treatment Period I)</title>
          <description>A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.</description>
          <population>FAS; LOCF imputation method was used for all time points.</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="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)</title>
        <description>A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)</title>
          <description>A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)</title>
        <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)</title>
          <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.4"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.4"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)</title>
        <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)</title>
          <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.4"/>
                    <measurement group_id="O3" value="0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.0" spread="0.4"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.0" spread="0.3"/>
                    <measurement group_id="O3" value="0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.1"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.3"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.3"/>
                    <measurement group_id="O3" value="0.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="0.0" spread="0.3"/>
                    <measurement group_id="O3" value="0.0" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.3"/>
                    <measurement group_id="O3" value="-0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="0.0" spread="0.3"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.0" spread="0.2"/>
                    <measurement group_id="O3" value="-0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.3"/>
                    <measurement group_id="O3" value="0.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CGI-BP-S: Depression (Treatment Period I)</title>
        <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CGI-BP-S: Depression (Treatment Period I)</title>
          <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.7"/>
                    <measurement group_id="O2" value="-0.5" spread="0.8"/>
                    <measurement group_id="O3" value="-0.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.9"/>
                    <measurement group_id="O2" value="-0.8" spread="1.0"/>
                    <measurement group_id="O3" value="-0.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.1"/>
                    <measurement group_id="O2" value="-1.0" spread="1.1"/>
                    <measurement group_id="O3" value="-0.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.1"/>
                    <measurement group_id="O2" value="-1.2" spread="1.2"/>
                    <measurement group_id="O3" value="-1.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.2"/>
                    <measurement group_id="O2" value="-1.3" spread="1.2"/>
                    <measurement group_id="O3" value="-1.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.4"/>
                    <measurement group_id="O2" value="-1.4" spread="1.3"/>
                    <measurement group_id="O3" value="-1.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)</title>
        <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)</title>
          <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
          <units>units on a sale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="0.8"/>
                    <measurement group_id="O3" value="-0.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="1.1"/>
                    <measurement group_id="O3" value="-0.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.0" spread="1.2"/>
                    <measurement group_id="O3" value="-1.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.2" spread="1.2"/>
                    <measurement group_id="O3" value="-1.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.4" spread="1.2"/>
                    <measurement group_id="O3" value="-1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.5" spread="1.3"/>
                    <measurement group_id="O3" value="-1.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.5" spread="1.4"/>
                    <measurement group_id="O3" value="-1.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.5" spread="1.4"/>
                    <measurement group_id="O3" value="-1.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.7"/>
                    <measurement group_id="O2" value="-1.5" spread="1.4"/>
                    <measurement group_id="O3" value="-1.7" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.8"/>
                    <measurement group_id="O2" value="-1.7" spread="1.3"/>
                    <measurement group_id="O3" value="-1.7" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.9"/>
                    <measurement group_id="O2" value="-1.7" spread="1.4"/>
                    <measurement group_id="O3" value="-2.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.0"/>
                    <measurement group_id="O2" value="-1.8" spread="1.4"/>
                    <measurement group_id="O3" value="-1.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.1"/>
                    <measurement group_id="O2" value="-2.1" spread="1.4"/>
                    <measurement group_id="O3" value="-2.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.2"/>
                    <measurement group_id="O2" value="-2.4" spread="1.2"/>
                    <measurement group_id="O3" value="-2.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.3"/>
                    <measurement group_id="O2" value="-2.4" spread="1.4"/>
                    <measurement group_id="O3" value="-2.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.2"/>
                    <measurement group_id="O2" value="-2.6" spread="1.4"/>
                    <measurement group_id="O3" value="-2.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.3"/>
                    <measurement group_id="O2" value="-2.5" spread="1.3"/>
                    <measurement group_id="O3" value="-2.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.3"/>
                    <measurement group_id="O2" value="-2.3" spread="1.4"/>
                    <measurement group_id="O3" value="-2.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.3"/>
                    <measurement group_id="O2" value="-2.5" spread="1.3"/>
                    <measurement group_id="O3" value="-2.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.4"/>
                    <measurement group_id="O2" value="-2.7" spread="1.3"/>
                    <measurement group_id="O3" value="-2.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.4"/>
                    <measurement group_id="O2" value="-1.8" spread="1.6"/>
                    <measurement group_id="O3" value="-1.6" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)</title>
        <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)</title>
          <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.7"/>
                    <measurement group_id="O2" value="-0.4" spread="0.8"/>
                    <measurement group_id="O3" value="-0.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.9"/>
                    <measurement group_id="O2" value="-0.7" spread="1.0"/>
                    <measurement group_id="O3" value="-0.7" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.0"/>
                    <measurement group_id="O2" value="-0.9" spread="1.1"/>
                    <measurement group_id="O3" value="-0.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.1"/>
                    <measurement group_id="O2" value="-1.1" spread="1.1"/>
                    <measurement group_id="O3" value="-1.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.2"/>
                    <measurement group_id="O2" value="-1.2" spread="1.2"/>
                    <measurement group_id="O3" value="-1.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.3"/>
                    <measurement group_id="O2" value="-1.4" spread="1.3"/>
                    <measurement group_id="O3" value="-1.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)</title>
        <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)</title>
          <description>The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.4" spread="0.8"/>
                    <measurement group_id="O3" value="-0.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="1.0"/>
                    <measurement group_id="O3" value="-0.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="1.1"/>
                    <measurement group_id="O3" value="-1.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.1" spread="1.2"/>
                    <measurement group_id="O3" value="-1.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="1.2"/>
                    <measurement group_id="O3" value="-1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.4" spread="1.3"/>
                    <measurement group_id="O3" value="-1.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.4" spread="1.4"/>
                    <measurement group_id="O3" value="-1.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.4" spread="1.5"/>
                    <measurement group_id="O3" value="-1.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.7"/>
                    <measurement group_id="O2" value="-1.4" spread="1.4"/>
                    <measurement group_id="O3" value="-1.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.8"/>
                    <measurement group_id="O2" value="-1.6" spread="1.3"/>
                    <measurement group_id="O3" value="-1.7" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.9"/>
                    <measurement group_id="O2" value="-1.6" spread="1.4"/>
                    <measurement group_id="O3" value="-1.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.0"/>
                    <measurement group_id="O2" value="-1.7" spread="1.4"/>
                    <measurement group_id="O3" value="-1.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.0"/>
                    <measurement group_id="O2" value="-2.0" spread="1.4"/>
                    <measurement group_id="O3" value="-1.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.1"/>
                    <measurement group_id="O2" value="-2.2" spread="1.3"/>
                    <measurement group_id="O3" value="-1.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.3"/>
                    <measurement group_id="O2" value="-2.2" spread="1.4"/>
                    <measurement group_id="O3" value="-2.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.2"/>
                    <measurement group_id="O2" value="-2.4" spread="1.5"/>
                    <measurement group_id="O3" value="-2.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.3"/>
                    <measurement group_id="O2" value="-2.3" spread="1.3"/>
                    <measurement group_id="O3" value="-2.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.3"/>
                    <measurement group_id="O2" value="-2.2" spread="1.5"/>
                    <measurement group_id="O3" value="-2.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.2"/>
                    <measurement group_id="O2" value="-2.4" spread="1.5"/>
                    <measurement group_id="O3" value="-2.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.3"/>
                    <measurement group_id="O2" value="-2.6" spread="1.4"/>
                    <measurement group_id="O3" value="-2.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.3"/>
                    <measurement group_id="O2" value="-1.7" spread="1.6"/>
                    <measurement group_id="O3" value="-1.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)</title>
        <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)</title>
          <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.3"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.2"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.2"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.3"/>
                    <measurement group_id="O2" value="4.0" spread="0.4"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.3"/>
                    <measurement group_id="O2" value="3.9" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.3"/>
                    <measurement group_id="O2" value="3.9" spread="0.3"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGI-BP-C: Mania (Combined Treatment Period I and II)</title>
        <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 1)</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>CGI-BP-C: Mania (Combined Treatment Period I and II)</title>
          <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.3"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.3"/>
                    <measurement group_id="O3" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" spread="0.3"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.1"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.5"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.5"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.5"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.5"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.5"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.3"/>
                    <measurement group_id="O3" value="4.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.3"/>
                    <measurement group_id="O2" value="4.0" spread="0.4"/>
                    <measurement group_id="O3" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.3"/>
                    <measurement group_id="O2" value="4.0" spread="0.2"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.0"/>
                    <measurement group_id="O3" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.0"/>
                    <measurement group_id="O3" value="4.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.4"/>
                    <measurement group_id="O2" value="4.0" spread="0.0"/>
                    <measurement group_id="O3" value="4.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.5"/>
                    <measurement group_id="O2" value="3.9" spread="0.3"/>
                    <measurement group_id="O3" value="4.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGI-BP-C: Depression (Treatment Period I)</title>
        <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>CGI-BP-C: Depression (Treatment Period I)</title>
          <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.8"/>
                    <measurement group_id="O2" value="3.5" spread="0.8"/>
                    <measurement group_id="O3" value="3.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.0"/>
                    <measurement group_id="O2" value="3.1" spread="0.9"/>
                    <measurement group_id="O3" value="3.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.2"/>
                    <measurement group_id="O2" value="2.9" spread="0.9"/>
                    <measurement group_id="O3" value="3.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="1.3"/>
                    <measurement group_id="O2" value="2.8" spread="1.0"/>
                    <measurement group_id="O3" value="2.9" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="1.3"/>
                    <measurement group_id="O2" value="2.7" spread="1.0"/>
                    <measurement group_id="O3" value="2.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.4"/>
                    <measurement group_id="O2" value="2.6" spread="1.1"/>
                    <measurement group_id="O3" value="2.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGI-BP-C: Depression (Combined Treatment Period I and II)</title>
        <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 1)</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputtion was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>CGI-BP-C: Depression (Combined Treatment Period I and II)</title>
          <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputtion was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.5" spread="0.8"/>
                    <measurement group_id="O3" value="3.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.1" spread="0.9"/>
                    <measurement group_id="O3" value="3.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.9" spread="0.9"/>
                    <measurement group_id="O3" value="2.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.7" spread="1.0"/>
                    <measurement group_id="O3" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.6" spread="1.0"/>
                    <measurement group_id="O3" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.5" spread="1.1"/>
                    <measurement group_id="O3" value="2.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.5" spread="1.1"/>
                    <measurement group_id="O3" value="2.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.2"/>
                    <measurement group_id="O2" value="2.6" spread="1.2"/>
                    <measurement group_id="O3" value="2.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.2"/>
                    <measurement group_id="O2" value="2.6" spread="1.2"/>
                    <measurement group_id="O3" value="2.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.2"/>
                    <measurement group_id="O2" value="2.4" spread="1.0"/>
                    <measurement group_id="O3" value="2.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.2"/>
                    <measurement group_id="O2" value="2.5" spread="1.3"/>
                    <measurement group_id="O3" value="2.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.0"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                    <measurement group_id="O3" value="2.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.9"/>
                    <measurement group_id="O2" value="2.1" spread="1.1"/>
                    <measurement group_id="O3" value="2.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.9"/>
                    <measurement group_id="O2" value="1.9" spread="0.9"/>
                    <measurement group_id="O3" value="2.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.0"/>
                    <measurement group_id="O2" value="2.0" spread="1.2"/>
                    <measurement group_id="O3" value="2.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.0"/>
                    <measurement group_id="O2" value="1.8" spread="0.9"/>
                    <measurement group_id="O3" value="2.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.0"/>
                    <measurement group_id="O2" value="1.8" spread="0.8"/>
                    <measurement group_id="O3" value="2.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.9"/>
                    <measurement group_id="O2" value="2.0" spread="1.0"/>
                    <measurement group_id="O3" value="1.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.0"/>
                    <measurement group_id="O2" value="1.9" spread="0.9"/>
                    <measurement group_id="O3" value="1.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.0"/>
                    <measurement group_id="O2" value="1.7" spread="0.9"/>
                    <measurement group_id="O3" value="1.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.2"/>
                    <measurement group_id="O2" value="2.5" spread="1.4"/>
                    <measurement group_id="O3" value="2.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGI-BP-C: Overall Bipolar Illness (Treatment Period I)</title>
        <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>FAS; LOCF imputation method was used for all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>CGI-BP-C: Overall Bipolar Illness (Treatment Period I)</title>
          <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.</description>
          <population>FAS; LOCF imputation method was used for all time points.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.8"/>
                    <measurement group_id="O2" value="3.5" spread="0.8"/>
                    <measurement group_id="O3" value="3.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.0"/>
                    <measurement group_id="O2" value="3.1" spread="0.9"/>
                    <measurement group_id="O3" value="3.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.2"/>
                    <measurement group_id="O2" value="2.9" spread="0.9"/>
                    <measurement group_id="O3" value="3.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.3"/>
                    <measurement group_id="O2" value="2.8" spread="1.0"/>
                    <measurement group_id="O3" value="2.9" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.4"/>
                    <measurement group_id="O2" value="2.7" spread="1.0"/>
                    <measurement group_id="O3" value="2.9" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.5"/>
                    <measurement group_id="O2" value="2.6" spread="1.1"/>
                    <measurement group_id="O3" value="2.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)</title>
        <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 1)</time_frame>
        <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)</title>
          <description>The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.5" spread="0.8"/>
                    <measurement group_id="O3" value="3.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.1" spread="0.9"/>
                    <measurement group_id="O3" value="3.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.9" spread="0.9"/>
                    <measurement group_id="O3" value="2.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.7" spread="1.0"/>
                    <measurement group_id="O3" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.6" spread="1.1"/>
                    <measurement group_id="O3" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.5" spread="1.1"/>
                    <measurement group_id="O3" value="2.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.5" spread="1.1"/>
                    <measurement group_id="O3" value="2.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.2"/>
                    <measurement group_id="O2" value="2.6" spread="1.2"/>
                    <measurement group_id="O3" value="2.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.2"/>
                    <measurement group_id="O2" value="2.6" spread="1.2"/>
                    <measurement group_id="O3" value="2.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.2"/>
                    <measurement group_id="O2" value="2.4" spread="1.0"/>
                    <measurement group_id="O3" value="2.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.1"/>
                    <measurement group_id="O2" value="2.5" spread="1.3"/>
                    <measurement group_id="O3" value="2.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.0"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                    <measurement group_id="O3" value="2.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.9"/>
                    <measurement group_id="O2" value="2.1" spread="1.1"/>
                    <measurement group_id="O3" value="2.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.9"/>
                    <measurement group_id="O2" value="1.9" spread="0.9"/>
                    <measurement group_id="O3" value="2.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.1"/>
                    <measurement group_id="O2" value="2.1" spread="1.2"/>
                    <measurement group_id="O3" value="2.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.0"/>
                    <measurement group_id="O2" value="1.9" spread="1.1"/>
                    <measurement group_id="O3" value="2.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.0"/>
                    <measurement group_id="O2" value="1.8" spread="0.8"/>
                    <measurement group_id="O3" value="2.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.9"/>
                    <measurement group_id="O2" value="2.0" spread="1.0"/>
                    <measurement group_id="O3" value="1.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.0"/>
                    <measurement group_id="O2" value="1.9" spread="1.0"/>
                    <measurement group_id="O3" value="2.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.0"/>
                    <measurement group_id="O2" value="1.7" spread="0.9"/>
                    <measurement group_id="O3" value="1.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.2"/>
                    <measurement group_id="O2" value="2.5" spread="1.4"/>
                    <measurement group_id="O3" value="2.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (Treatment Period I)</title>
        <description>An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.</description>
        <time_frame>Up to 8 weeks</time_frame>
        <population>Safety Analysis Set (SAF), which included participants who received at least one dose of study drug for Treatment Period I.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (Treatment Period I)</title>
          <description>An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.</description>
          <population>Safety Analysis Set (SAF), which included participants who received at least one dose of study drug for Treatment Period I.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs that caused study drug discontimuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AEs that caused study drug discont.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (Combined Treatment Period I and II)</title>
        <description>An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.</description>
        <time_frame>Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E &amp; FK949E 300 mg / FK949E groups, from week 0 to week 52)</time_frame>
        <population>SAF for combined Treatment Periods I and II, which included participants who were treated with FK949E at least one time.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (Combined Treatment Period I and II)</title>
          <description>An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.</description>
          <population>SAF for combined Treatment Periods I and II, which included participants who were treated with FK949E at least one time.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs that caused study drug discontimuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related AEs that caused study drug discont</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)</title>
        <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity.</description>
        <time_frame>Baseline and Weeks 4, 8</time_frame>
        <population>SAF participants with available data at each time point; LOCF was used for end of Treatment Period I.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>Treatment Period I: FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)</title>
          <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity.</description>
          <population>SAF participants with available data at each time point; LOCF was used for end of Treatment Period I.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.5"/>
                    <measurement group_id="O2" value="0.0" spread="0.7"/>
                    <measurement group_id="O3" value="0.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.0" spread="0.7"/>
                    <measurement group_id="O3" value="0.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Treatment Period I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.6"/>
                    <measurement group_id="O2" value="0.0" spread="0.8"/>
                    <measurement group_id="O3" value="0.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)</title>
        <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)</title>
          <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.7"/>
                    <measurement group_id="O3" value="0.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.7"/>
                    <measurement group_id="O3" value="0.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.1" spread="0.8"/>
                    <measurement group_id="O3" value="0.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.9"/>
                    <measurement group_id="O2" value="0.1" spread="0.7"/>
                    <measurement group_id="O3" value="0.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.8"/>
                    <measurement group_id="O2" value="0.1" spread="1.0"/>
                    <measurement group_id="O3" value="0.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.7"/>
                    <measurement group_id="O2" value="-0.0" spread="0.6"/>
                    <measurement group_id="O3" value="0.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.7"/>
                    <measurement group_id="O2" value="0.0" spread="0.7"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.4"/>
                    <measurement group_id="O2" value="-0.0" spread="0.6"/>
                    <measurement group_id="O3" value="-0.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.0" spread="0.6"/>
                    <measurement group_id="O3" value="-0.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.7"/>
                    <measurement group_id="O2" value="-0.0" spread="0.7"/>
                    <measurement group_id="O3" value="0.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)</title>
        <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe).</description>
        <time_frame>Baseline and Weeks 4, 8</time_frame>
        <population>SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)</title>
          <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe).</description>
          <population>SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.4"/>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="0.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Treatment Period I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.4"/>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="-0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)</title>
        <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)</title>
          <description>The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as &quot;normal.&quot; Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.</population>
          <units>umits 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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="0.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.7"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.7"/>
                    <measurement group_id="O2" value="-0.0" spread="0.6"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.4"/>
                    <measurement group_id="O2" value="-0.0" spread="0.7"/>
                    <measurement group_id="O3" value="-0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="-0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.2"/>
                    <measurement group_id="O2" value="-0.1" spread="0.4"/>
                    <measurement group_id="O3" value="-0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.3"/>
                    <measurement group_id="O2" value="-0.1" spread="0.4"/>
                    <measurement group_id="O3" value="-0.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.4"/>
                    <measurement group_id="O2" value="-0.1" spread="0.5"/>
                    <measurement group_id="O3" value="-0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)</title>
        <description>The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates &quot;Absent&quot; or &quot;Normal.&quot;</description>
        <time_frame>Baseline and Weeks 1, 2, 3, 4, 6, 8</time_frame>
        <population>SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)</title>
          <description>The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates &quot;Absent&quot; or &quot;Normal.&quot;</description>
          <population>SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.6"/>
                    <measurement group_id="O2" value="-0.6" spread="1.8"/>
                    <measurement group_id="O3" value="-0.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.4"/>
                    <measurement group_id="O2" value="-1.0" spread="1.5"/>
                    <measurement group_id="O3" value="-0.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.9"/>
                    <measurement group_id="O2" value="-1.2" spread="1.7"/>
                    <measurement group_id="O3" value="-0.7" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.7"/>
                    <measurement group_id="O2" value="-1.3" spread="2.0"/>
                    <measurement group_id="O3" value="-0.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.2"/>
                    <measurement group_id="O2" value="-1.4" spread="2.1"/>
                    <measurement group_id="O3" value="-0.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.6"/>
                    <measurement group_id="O2" value="-1.7" spread="2.3"/>
                    <measurement group_id="O3" value="-0.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Treatment Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="2.1"/>
                    <measurement group_id="O2" value="-1.6" spread="2.3"/>
                    <measurement group_id="O3" value="-0.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in YMRS (Combined Treatment Period I and II)</title>
        <description>The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates &quot;Absent&quot; or &quot;Normal.&quot; Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
        <time_frame>Baseline (Week 0 for FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in YMRS (Combined Treatment Period I and II)</title>
          <description>The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates &quot;Absent&quot; or &quot;Normal.&quot; Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="1.8"/>
                    <measurement group_id="O3" value="-0.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.0" spread="1.5"/>
                    <measurement group_id="O3" value="-0.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.2" spread="1.7"/>
                    <measurement group_id="O3" value="-0.7" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="2.0"/>
                    <measurement group_id="O3" value="-0.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.4" spread="2.1"/>
                    <measurement group_id="O3" value="-0.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="59"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.7" spread="2.3"/>
                    <measurement group_id="O3" value="-0.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.6" spread="2.1"/>
                    <measurement group_id="O3" value="-0.8" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.2" spread="1.6"/>
                    <measurement group_id="O3" value="-1.0" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.5"/>
                    <measurement group_id="O2" value="-1.3" spread="1.6"/>
                    <measurement group_id="O3" value="-1.1" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.7"/>
                    <measurement group_id="O2" value="-1.6" spread="1.9"/>
                    <measurement group_id="O3" value="-1.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.8"/>
                    <measurement group_id="O2" value="-1.3" spread="2.1"/>
                    <measurement group_id="O3" value="-0.9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.9"/>
                    <measurement group_id="O2" value="-1.6" spread="2.0"/>
                    <measurement group_id="O3" value="-1.1" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.8"/>
                    <measurement group_id="O2" value="-1.5" spread="2.2"/>
                    <measurement group_id="O3" value="-0.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.9"/>
                    <measurement group_id="O2" value="-1.4" spread="1.9"/>
                    <measurement group_id="O3" value="-0.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.9"/>
                    <measurement group_id="O2" value="-1.6" spread="2.0"/>
                    <measurement group_id="O3" value="-1.1" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.6"/>
                    <measurement group_id="O2" value="-1.4" spread="2.4"/>
                    <measurement group_id="O3" value="-0.3" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.9"/>
                    <measurement group_id="O2" value="-1.3" spread="2.4"/>
                    <measurement group_id="O3" value="-0.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.8"/>
                    <measurement group_id="O2" value="-1.6" spread="2.1"/>
                    <measurement group_id="O3" value="-1.0" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="2.0"/>
                    <measurement group_id="O2" value="-1.7" spread="1.9"/>
                    <measurement group_id="O3" value="-1.1" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.7"/>
                    <measurement group_id="O2" value="-1.9" spread="2.1"/>
                    <measurement group_id="O3" value="-1.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.8"/>
                    <measurement group_id="O2" value="-1.9" spread="2.0"/>
                    <measurement group_id="O3" value="-1.2" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="2.2"/>
                    <measurement group_id="O2" value="-1.6" spread="2.0"/>
                    <measurement group_id="O3" value="-0.4" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.</description>
        <time_frame>Weeks 4, 8</time_frame>
        <population>SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.</description>
          <population>SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="173"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4: Wish to be dead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Suicidal thoughts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Suicidal thoughts w/ method</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Suicidal intent (w/o plan)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="12"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Suicidal intent w/ plan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="12"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Wish to be dead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Suicidal thoughts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Suicidal thoughts w/ method</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Suicidal intent (w/o plan)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Suicidal intent w/ plan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Wish to be dead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Suicidal thoughts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endf of Period I: Suicidal thoughts w/ method</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Suicidal intent (w/o plan)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="16"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Suicidal intent w/ plan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" 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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
          <units>particpants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="5"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</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="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="5"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</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="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="27"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="5"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</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="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="27"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).</description>
        <time_frame>Weeks 4, 8</time_frame>
        <population>SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg</title>
            <description>After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg</title>
            <description>After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).</description>
          <population>SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="173"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4: Suicide attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Self-injury w/o intent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Discontinued attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Interrupted attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Preliminary act to suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Suicidal behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Completed suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Suicide attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Self-injury w/o intent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Discontinued attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Interrupted attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Preliminary act to suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Suicidal behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Completed suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Suicide attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Self-injury w/o intent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Discontinued attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Interrupted attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Preliminary act to suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Suicidal behavior</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Period I: Completed suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endof combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)</title>
        <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
        <time_frame>Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E &amp; FK949E 300 mg/FK949E from week 4)</time_frame>
        <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / FK949E</title>
            <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O2">
            <title>FK949E 150 mg / FK949E</title>
            <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
          <group group_id="O3">
            <title>FK949E 300 mg / FK949E</title>
            <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)</title>
          <description>The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.</description>
          <population>SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.</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="120"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="123"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="118"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="111"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="105"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="98"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="92"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="88"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="83"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="76"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="74"/>
                  </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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of combined treatment period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="176"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 54 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Period I: Placebo</title>
          <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="E2">
          <title>Treatment Period I: FK949E 150 mg</title>
          <description>After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="E3">
          <title>Treatment Period I: FK949E 300 mg</title>
          <description>After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="E4">
          <title>Treatment Period I + II: Placebo / FK949E</title>
          <description>Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="E5">
          <title>Treatment Period I + II: FK949E 150 mg / FK949E</title>
          <description>Participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
        <group group_id="E6">
          <title>Treatment Period I + II: FK949E 300 mg / FK949E</title>
          <description>Participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</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="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="62" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="140" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="106" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="59" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="164" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperprolactinemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="22" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="51" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="40" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="36" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="58" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood creatinine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood prolactin increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Tri-iodothyronine free increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Bradykinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="80" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="59" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="34" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="97" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Hypomania</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="179"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="179"/>
              </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>Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head of Clinical Development Administration</name_or_title>
      <organization>Astellas Pharma Inc.</organization>
      <email>Astellas.resultsdisclosure@astellas.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/NCT01725308
org study id: 6949-CL-0021
nct id: NCT01725308
lead sponsor: 
has dmc: No
In period I, the treatment effect of FK949E was compared with that of placebo in a blind
      manner in bipolar disorder patients with major depressive episodes. In period II, the
      long-term safety and efficacy of FK949E was evaluated.
This study consisted of two parts. In Treatment Period I, FK949E or placebo was administered
      orally in a blind manner to bipolar disorder patients with major depressive episodes, with
      the aim of evaluating the superiority of FK949E over placebo and the dose response of two
      doses of FK949E based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) total
      score. In Treatment Period II, the long-term safety, efficacy and pharmacokinetics of
      open-label FK949E was evaluated in patients who completed Treatment Period I. An analysis was
      performed for data in Treatment Period I and another analysis was done for data in combined
      Treatment Periods I and II.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
time frame: Baseline and Week 8
description: The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
measure: Change From Baseline in MADRS Total Score (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
measure: Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Number of Participants With MADRS Response (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
measure: Number of Participants With MADRS Response (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Number of Participants With MADRS Remission (Treatment Period I)
time frame: Weeks 1, 2, 3, 4, 6, 8
description: MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
measure: Number of Participants With MADRS Remission (Combined Treatment Period I and II)
time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.
measure: Change From Baseline in HAM-D17 (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52
description: The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Number of Participants With HAM-D17 Response (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.
measure: Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52
description: A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).
measure: Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Change From Baseline in CGI-BP-S: Depression (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).
measure: Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).
measure: Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)
time frame: Weeks 1, 2, 3, 4, 6, 8
description: The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.
measure: CGI-BP-C: Mania (Combined Treatment Period I and II)
time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)
description: The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: CGI-BP-C: Depression (Treatment Period I)
time frame: Weeks 1, 2, 3, 4, 6, 8
description: The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.
measure: CGI-BP-C: Depression (Combined Treatment Period I and II)
time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)
description: The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: CGI-BP-C: Overall Bipolar Illness (Treatment Period I)
time frame: Weeks 1, 2, 3, 4, 6, 8
description: The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.
measure: CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)
time frame: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)
description: The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With Adverse Events (Treatment Period I)
time frame: Up to 8 weeks
description: An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.
measure: Number of Participants With Adverse Events (Combined Treatment Period I and II)
time frame: Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E & FK949E 300 mg / FK949E groups, from week 0 to week 52)
description: An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.
measure: Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)
time frame: Baseline and Weeks 4, 8
description: The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as "normal." The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity.
measure: Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52
description: The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as "normal." The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)
time frame: Baseline and Weeks 4, 8
description: The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as "normal." Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe).
measure: Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52
description: The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as "normal." Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)
time frame: Baseline and Weeks 1, 2, 3, 4, 6, 8
description: The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates "Absent" or "Normal."
measure: Change From Baseline in YMRS (Combined Treatment Period I and II)
time frame: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52
description: The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates "Absent" or "Normal." Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.
measure: Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)
time frame: Weeks 4, 8
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)
time frame: Weeks 4, 8
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10
measure: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)
time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)
description: The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
arm group label: FK949E 150 mg
arm group type: Experimental
description: After 2 days of up-titration, participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
arm group label: FK949E 300 mg
arm group type: Experimental
description: After 4 days of up-titration, participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I and were evaluated against the transition criteria to transfer to Treatment Period II. If transition criteria were not met, participants underwent to a dose-tapering period (1 week) and a follow-up period (1 week) thereafter. If transition criteria were met, participants went into Treatment Period II.
arm group label: Placebo / FK949E
arm group type: Experimental
description: Participants received placebo administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive placebo for 4 weeks, followed by a 1-week dose adjustment period, and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
arm group label: FK949E 150 mg / FK949E
arm group type: Experimental
description: After 2 days of up-titration, participants received FK949E 150 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 150 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
arm group label: FK949E 300 mg / FK949E
arm group type: Experimental
description: After 4 days of up-titration, participants received FK949E 300 mg administered orally once daily at bedtime for 8 weeks in Treatment Period I. Participants who met the transition criteria continued to Treatment Period II which consisted of a transition period in which participants continued to receive FK949E 300 mg for 4 weeks followed by a 1-week dose-adjustment period and a treatment period in which participants received either open-label FK949E 150 mg or 300 mg (depending on dose increase or reduction guidelines) administered orally for 39 weeks. Participants underwent a dose-tapering period (1 week) and a follow-up period (1 week) thereafter.
intervention type: Drug
intervention name: FK949E
description: Taken by mouth (orally).
arm group label: FK949E 150 mg
arm group label: FK949E 150 mg / FK949E
arm group label: FK949E 300 mg
arm group label: FK949E 300 mg / FK949E
arm group label: Placebo / FK949E
other name: quetiapine
intervention type: Drug
intervention name: Placebo
description: Taken by mouth (orally).
arm group label: Placebo
arm group label: Placebo / FK949E
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
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country: Japan
url: https://www.astellasclinicalstudyresults.com/study.aspx?ID=221
description: Link to results on Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Bipolar Disorder
mesh term: Quetiapine Fumarate
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
participant flow: 
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certain agreements: 
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