<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/NCT03001557</url>
  </required_header>
  <id_info>
    <org_study_id>E2006-G000-202</org_study_id>
    <secondary_id>2017-003306-40</secondary_id>
    <nct_id>NCT03001557</nct_id>
  </id_info>
  <brief_title>Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Purdue Pharma LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to determine the dose response of lemborexant (LEM) on the&#xD;
      change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters,&#xD;
      and circadian-rhythm related parameters. Following the eligibility screening period, eligible&#xD;
      participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks.&#xD;
      After a 2-week follow-up period, eligible participants may enter an open-label extension&#xD;
      period for up to 30 months or until the program discontinuation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">April 17, 2020</completion_date>
  <primary_completion_date type="Actual">July 26, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (&lt;=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the aMeanDurWB During Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the aMeanDurWB During Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean aWE During Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean aWE During Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean aWE During Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean WFI During Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean WFI During Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean WFI During Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the Mean Duration of Sleep Bouts (aMeanDurSB) During Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the aMeanDurSB During Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the aMeanDurSB During Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the aMeanDurSB During Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean Interdaily Stability (IS) Over Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean IS Over Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean IS Over Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Mean IS Over Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Average Activity Counts Across Least Active 5-hour Period (L5) Per 24-Hour Period Over Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the Average Activity Count During the Most Active 10-hour Period (M10) Per 24-Hour Period Over Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Amplitude of the Rest-activity Rhythm (AMP) Over Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in AMP Over Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in AMP Over Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in AMP Over Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in Relative Amplitude in the Rest-activity Rhythm (RA) Over Week 1 of Treatment</measure>
    <time_frame>Baseline, Week 1</time_frame>
    <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in RA Over Week 2 of Treatment</measure>
    <time_frame>Baseline, Week 2</time_frame>
    <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in RA Over Week 3 of Treatment</measure>
    <time_frame>Baseline, Week 3</time_frame>
    <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core Phase: Change From Baseline in RA Over Week 4 of Treatment</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>First dose of study drug (Day 1) to 14 days after last dose of study drug (approximately up to 2 years 7 months)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Core Phase: Number of Participants in Each Category With Clinician's Global Impression of Change-Irregular Sleep-Wake Rhythm Disorder (CGIC-ISWRD) Global Score at Day 29</measure>
    <time_frame>Day 29</time_frame>
    <description>The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 [marked improvement] to 7 [marked worsening]).</description>
  </other_outcome>
  <other_outcome>
    <measure>Core Phase: Change From Baseline in the Neuropsychiatric Inventory (NPI-10) Total Score at Day 29</measure>
    <time_frame>Baseline, Day 29</time_frame>
    <description>The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) * Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.</description>
  </other_outcome>
  <other_outcome>
    <measure>Core Phase: Change From Baseline in the Sleep Disorders Inventory (SDI) Score at Day 29</measure>
    <time_frame>Baseline, Day 29</time_frame>
    <description>The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).</description>
  </other_outcome>
  <other_outcome>
    <measure>Extension Phase: Change From Baseline in SDI Total Score.</measure>
    <time_frame>Baseline, Day 133, 223, 313, 343, 373, 403, 493, 583, 673, and 763</time_frame>
    <description>The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Irregular Sleep-Wake Rhythm Disorder</condition>
  <arm_group>
    <arm_group_label>Lemborexant 2.5 milligrams (mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take one lemborexant 2.5 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lemborexant 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take one lemborexant 5 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lemborexant 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take one lemborexant 10 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lemborexant 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take one lemborexant 5 mg tablet and one lemborexant 10 mg tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lemborexant-matched placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take two lemborexant-matched placebo tablets orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lemborexant 2.5 mg</intervention_name>
    <description>Lemborexant 2.5 mg tablets</description>
    <arm_group_label>Lemborexant 2.5 milligrams (mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lemborexant 5 mg</intervention_name>
    <description>Lemborexant 5 mg tablets</description>
    <arm_group_label>Lemborexant 5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lemborexant 10 mg</intervention_name>
    <description>Lemborexant 10 mg tablets</description>
    <arm_group_label>Lemborexant 10 mg</arm_group_label>
    <arm_group_label>Lemborexant 15 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lemborexant 15 mg</intervention_name>
    <description>Lemborexant 5 mg and 10 mg tablets</description>
    <arm_group_label>Lemborexant 15 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lemborexant-matched placebo</intervention_name>
    <description>Lemborexant-matched placebo tablets</description>
    <arm_group_label>Lemborexant 10 mg</arm_group_label>
    <arm_group_label>Lemborexant 2.5 milligrams (mg)</arm_group_label>
    <arm_group_label>Lemborexant 5 mg</arm_group_label>
    <arm_group_label>Lemborexant-matched placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Core Study):&#xD;
&#xD;
          -  Male or female, age 60 to 90 years at the time of informed consent&#xD;
&#xD;
          -  Able to provide informed consent. If a participant lacks capacity to consent in the&#xD;
             investigator's opinion, the participant's assent should be obtained, if required in&#xD;
             accordance with local laws, regulations and customs, and the written informed consent&#xD;
             of a legal representative should be obtained (capacity to consent and definition of&#xD;
             legal representative should be determined in accordance with applicable local laws and&#xD;
             regulations).&#xD;
&#xD;
          -  Documentation of diagnosis with Alzheimer's disease dementia (AD-D) on the basis of&#xD;
             the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines&#xD;
&#xD;
          -  Mini Mental State Examination 10 to 26 at Screening&#xD;
&#xD;
          -  Meets criteria for Circadian Rhythm Sleep Disorder, Irregular Sleep-Wake Type&#xD;
             (Diagnostic and Statistical Manual of Mental Disorders - 5th edition) and the 10th&#xD;
             revision of the International Classification of Diseases, as follows: Complaint by the&#xD;
             participant or caregiver of difficulty sleeping during the night and/or excessive&#xD;
             daytime sleepiness associated with multiple irregular sleep bouts during a 24-hour&#xD;
             period&#xD;
&#xD;
          -  Frequency of complaint of sleep and wake fragmentation ≥3 days per week&#xD;
&#xD;
          -  Duration of complaint of sleep and wake fragmentation ≥3 months&#xD;
&#xD;
          -  During the Screening Period, mean actigraphy-derived sleep efficiency (aSE) &lt;87.5%&#xD;
             within the defined nocturnal sleep period and mean actigraphy-derived wake efficiency&#xD;
             (aWE) &lt;87.5% during the defined wake period&#xD;
&#xD;
          -  Confirmation by actigraphy of a combination of sleep bouts of &gt;10 minutes during the&#xD;
             wake period plus wake bouts of &gt;10 minutes during the sleep period, totaling at least&#xD;
             4 bouts per 24 hours period, ≥ 3 days per week&#xD;
&#xD;
          -  Ambulatory and living in the community or in a residence not classified as a skilled&#xD;
             nursing facility (an assisted living facility with separate living quarters where&#xD;
             participants and their caregivers reside is acceptable)&#xD;
&#xD;
          -  Willing not to start a behavioral or other treatment program for sleep or wake&#xD;
             difficulties and not to start a new treatment for other symptoms of AD-D during&#xD;
             participation in the study&#xD;
&#xD;
          -  Has a reliable and competent caregiver (or caregiver and informants) who can accompany&#xD;
             the participant to study visits, administer study medication on a nightly basis and&#xD;
             provide information on the status of the participant&#xD;
&#xD;
          -  For participants taking a cholinesterase inhibitor and/or memantine, dosing regimen&#xD;
             must have been stable for at least 3 months&#xD;
&#xD;
        Inclusion Criteria (Extension Phase):&#xD;
&#xD;
          -  Completed the Core Study (End of Study [EOS] Visit). Participants who participated in&#xD;
             the Core Study and completed the EOS Visit within 30 days may return to participate in&#xD;
             the Extension Phase as long as there are no contraindications due to ongoing adverse&#xD;
             events or prohibited medications.&#xD;
&#xD;
        Inclusion Criteria for Caregivers:&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Spends at least 10 hours per week with the participant&#xD;
&#xD;
          -  Able to meet caregiver requirements&#xD;
&#xD;
          -  Willing to provide information on himself/herself regarding sleep quality and&#xD;
             caregiver Burden&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of vascular dementia, dementia following multiple strokes, or any&#xD;
             synucleinopathy / Lewy body disorder. This includes Dementia with Lewy Bodies and&#xD;
             Parkinson's disease with or without dementia.&#xD;
&#xD;
          -  A current diagnosis of moderate to severe obstructive sleep apnea (OSA) or central&#xD;
             sleep apnea, or current use of continuous positive airways pressure even if mild&#xD;
             severity of OSA, restless legs syndrome, periodic limb movement disorder (with&#xD;
             awakenings), or narcolepsy&#xD;
&#xD;
          -  An Apnea-Hypopnea Index or equivalent ≥15 events/hour on diagnostic sleep study&#xD;
             conducted prior to Baseline or within 6 months of Screening&#xD;
&#xD;
          -  A clinically significant movement disorder that would affect the differentiation of&#xD;
             sleep and wake by the actigraphy analytic algorithm&#xD;
&#xD;
          -  Current symptoms or history during the past year of Rapid Eye Movement Behavior&#xD;
             Disorder or sleep-related violent behavior&#xD;
&#xD;
          -  Probable Major Depression, as evidenced by score &gt;10 on the Cornell Scale for&#xD;
             Depression in Dementia at Screening&#xD;
&#xD;
          -  Unable to tolerate wearing the actigraph. At a minimum, participants must be able to&#xD;
             wear the actigraph for 5 complete days out of 7 days' data. A day will be considered&#xD;
             complete as long as data from 90% of the 24-hour period are able to be scored.&#xD;
&#xD;
          -  Excessive caffeine use that in the opinion of the investigator contributes to the&#xD;
             participant's Irregular Sleep-Wake Rhythm Disorder (ISWRD)&#xD;
&#xD;
          -  History of drug or alcohol dependency or abuse within approximately the previous 2&#xD;
             years&#xD;
&#xD;
          -  Reports habitually consuming more than 14 drinks containing alcohol per week or&#xD;
             habitually consumes alcohol within 3 hours before bedtime and unwilling to limit&#xD;
             alcohol intake to 2 or fewer drinks per day or forego having alcohol within 3 hours&#xD;
             before bedtime for the duration of his/her participation in the study&#xD;
&#xD;
          -  Known to be human immunodeficiency virus positive&#xD;
&#xD;
          -  Active viral hepatitis (B or C) as demonstrated by positive serology at Screening&#xD;
&#xD;
          -  A prolonged QTcF interval (QTcF &gt;450 milliseconds[ms]) as demonstrated by a repeated&#xD;
             electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF&#xD;
             interval &gt;450 ms) (participants with evidence of bundle branch block are not excluded&#xD;
             if the block is not clinically significant, as documented by the investigator in the&#xD;
             source document)&#xD;
&#xD;
          -  Current evidence of clinically significant disease that in the opinion of the&#xD;
             investigator(s) could affect the participant's safety or interfere with the study&#xD;
             assessments&#xD;
&#xD;
          -  Any history of a medical or psychiatric condition other than Alzheimer's Disease&#xD;
             dementia that in the opinion of the investigator(s) could affect the participant's&#xD;
             safety or interfere with the study assessments&#xD;
&#xD;
          -  History of malignancy within the previous 5 years except for adequately treated basal&#xD;
             cell or squamous cell skin cancer or cervical carcinoma in situ&#xD;
&#xD;
          -  Any suicidal ideation with intent with or without a plan, at the time of or within 6&#xD;
             months of Screening, as indicated by answering &quot;Yes&quot; to questions 4 and 5 on the&#xD;
             Suicidal Ideation section of the electronic version of the Columbia Suicide Severity&#xD;
             Rating Scale (eC-SSRS)&#xD;
&#xD;
          -  Any suicidal behavior within the past 10 years based on the eC-SSRS&#xD;
&#xD;
          -  History of violence toward the caregiver or others&#xD;
&#xD;
          -  Scheduled for surgery using general anesthesia during the study&#xD;
&#xD;
          -  Used any prohibited prescription or over-the-counter concomitant medications within 1&#xD;
             week or 5 half-lives, whichever is longer, before starting actigraphy during Screening&#xD;
&#xD;
          -  Used any modality of treatment for ISWRD between Screening and Randomization based on&#xD;
             approaches related to circadian rhythms, including phototherapy (light therapy),&#xD;
             melatonin and melatonin agonists&#xD;
&#xD;
          -  Failed treatment with Belsomra (efficacy and/or safety) following treatment with an&#xD;
             appropriate dose and of adequate duration in the opinion of the investigator&#xD;
&#xD;
          -  Transmeridian travel across more than 3 time zones between Screening and&#xD;
             Randomization, or plans to travel across more than 3 time zones during the study&#xD;
&#xD;
          -  Hypersensitivity to lemborexant or to its excipients&#xD;
&#xD;
          -  Currently enrolled in another clinical trial, except for observational studies with no&#xD;
             treatment component&#xD;
&#xD;
          -  Used any investigational drug or device before informed consent (ie, within 30 days or&#xD;
             5× the investigational drug half-life whichever is longer or 6 months for potential&#xD;
             disease-modifying drugs)&#xD;
&#xD;
          -  Previously participated in any clinical trial of lemborexant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037-0949</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #2</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #2</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Senior Services (NSS) Adult Day Care Center</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #2</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #2</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Norristown</city>
        <state>Pennsylvania</state>
        <zip>19401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facility #1</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>451-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Fujisawa</city>
        <state>Kanagawa</state>
        <zip>251-0038</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Kawasaki-shi</city>
        <state>Kanagawa</state>
        <zip>210-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Wako</city>
        <state>Saitama</state>
        <zip>351-0111</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Kodaira</city>
        <state>Tokyo</state>
        <zip>187-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Setagaya</city>
        <state>Tokyo</state>
        <zip>156-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Shinjuku</city>
        <state>Tokyo</state>
        <zip>169-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Tachikawa-shi</city>
        <state>Tokyo</state>
        <zip>190-8531</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brighton and Sussex Medical School</name>
      <address>
        <city>Brighton</city>
        <state>East Sussex</state>
        <zip>BN1 9PX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognitive Treatment and Research Unit</name>
      <address>
        <city>Crowborough</city>
        <state>East Sussex</state>
        <zip>TN6 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Edinburgh - PPDS</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH1 64UX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>January 3, 2020</results_first_submitted>
  <results_first_submitted_qc>January 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 14, 2020</results_first_posted>
  <disposition_first_submitted>July 22, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 22, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 29, 2019</disposition_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mild to Moderate Alzheimer's Disease Dementia</keyword>
  <keyword>sleep</keyword>
  <keyword>circadian rhythms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lemborexant</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03001557/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Core Phase</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03001557/SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Extension Phase</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03001557/SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 57 investigative sites in the United States, Japan and United Kingdom from 20 Dec 2016 to 17 Apr 2020.</recruitment_details>
      <pre_assignment_details>In Core phase, a total of 214 participants were screened, of which 151 were screen failures and 63 were randomized and enrolled in to the study. Of these 63 participants, 62 received the study treatment (1 participant was inadvertently randomized but did not receive any study drug). In Extension phase, a total of 25 participants who completed the Core Phase, gave consent to join Extension phase were enrolled and treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Core Phase: Lemborexant-matched Placebo</title>
          <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Core Phase: Lemborexant 2.5 mg</title>
          <description>Participants received one lemborexant 2.5 milligrams (mg) and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="P3">
          <title>Core Phase: Lemborexant 5 mg</title>
          <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="P4">
          <title>Core Phase: Lemborexant 10 mg</title>
          <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="P5">
          <title>Core Phase: Lemborexant 15 mg</title>
          <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="P6">
          <title>Extension Phase: Lemborexant 5 mg</title>
          <description>Participants who completed the core study end of study (EOS) visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for Irregular Sleep-Wake Rhythm Disorder (ISWRD) is discontinued or up to 30 months.</description>
        </group>
        <group group_id="P7">
          <title>Extension Phase: Lemborexant 10 mg</title>
          <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
        </group>
        <group group_id="P8">
          <title>Extension Phase: Lemborexant 15 mg</title>
          <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Core Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Extension Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="14"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="14"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative Reason</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Loss of caregiver</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Others</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety analysis set included the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Core Phase: Lemborexant-matched Placebo</title>
          <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Core Phase: Lemborexant 2.5 mg</title>
          <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="B3">
          <title>Core Phase: Lemborexant 5 mg</title>
          <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="B4">
          <title>Core Phase: Lemborexant 10 mg</title>
          <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="B5">
          <title>Core Phase: Lemborexant 15 mg</title>
          <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="B6">
          <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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="13"/>
            <count group_id="B5" value="12"/>
            <count group_id="B6" value="62"/>
          </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="75.3" spread="6.15"/>
                    <measurement group_id="B2" value="76.5" spread="6.32"/>
                    <measurement group_id="B3" value="76.9" spread="7.98"/>
                    <measurement group_id="B4" value="71.8" spread="7.05"/>
                    <measurement group_id="B5" value="71.9" spread="6.11"/>
                    <measurement group_id="B6" value="74.5" spread="6.94"/>
                  </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="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment</title>
        <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The full analysis set (FAS) included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment</title>
          <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The full analysis set (FAS) included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of sleep time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.34" spread="6.559"/>
                    <measurement group_id="O2" value="77.64" spread="7.883"/>
                    <measurement group_id="O3" value="78.45" spread="6.844"/>
                    <measurement group_id="O4" value="76.38" spread="8.037"/>
                    <measurement group_id="O5" value="77.35" spread="8.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="5.766"/>
                    <measurement group_id="O2" value="2.43" spread="3.910"/>
                    <measurement group_id="O3" value="3.87" spread="4.646"/>
                    <measurement group_id="O4" value="-0.17" spread="5.861"/>
                    <measurement group_id="O5" value="0.05" spread="4.475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment</title>
        <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment</title>
          <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of sleep time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.34" spread="6.559"/>
                    <measurement group_id="O2" value="77.64" spread="7.883"/>
                    <measurement group_id="O3" value="78.45" spread="6.844"/>
                    <measurement group_id="O4" value="76.38" spread="8.037"/>
                    <measurement group_id="O5" value="77.35" spread="8.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.31" spread="7.004"/>
                    <measurement group_id="O2" value="2.17" spread="2.833"/>
                    <measurement group_id="O3" value="1.65" spread="4.644"/>
                    <measurement group_id="O4" value="-1.41" spread="5.896"/>
                    <measurement group_id="O5" value="-0.07" spread="5.449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment</title>
        <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment</title>
          <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of sleep time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.34" spread="6.559"/>
                    <measurement group_id="O2" value="77.64" spread="7.883"/>
                    <measurement group_id="O3" value="78.45" spread="6.844"/>
                    <measurement group_id="O4" value="76.38" spread="8.037"/>
                    <measurement group_id="O5" value="77.35" spread="8.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.30" spread="10.552"/>
                    <measurement group_id="O2" value="1.68" spread="3.229"/>
                    <measurement group_id="O3" value="0.91" spread="7.571"/>
                    <measurement group_id="O4" value="-1.49" spread="4.442"/>
                    <measurement group_id="O5" value="1.10" spread="7.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment</title>
        <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment</title>
          <description>aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of sleep time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.34" spread="6.559"/>
                    <measurement group_id="O2" value="77.64" spread="7.883"/>
                    <measurement group_id="O3" value="78.45" spread="6.844"/>
                    <measurement group_id="O4" value="76.38" spread="8.037"/>
                    <measurement group_id="O5" value="77.35" spread="8.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="9.555"/>
                    <measurement group_id="O2" value="1.68" spread="4.696"/>
                    <measurement group_id="O3" value="0.00" spread="5.547"/>
                    <measurement group_id="O4" value="-1.04" spread="5.920"/>
                    <measurement group_id="O5" value="-0.81" spread="7.735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1099</p_value>
            <p_value_desc>Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>Least square mean (LSM) difference</param_type>
            <param_value>3.177</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.741</ci_lower_limit>
            <ci_upper_limit>7.096</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1576</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>2.802</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.119</ci_lower_limit>
            <ci_upper_limit>6.723</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6160</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.960</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.777</ci_lower_limit>
            <ci_upper_limit>2.857</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7135</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.713</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.160</ci_lower_limit>
            <ci_upper_limit>4.585</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment</title>
        <description>The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (&lt;=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment</title>
          <description>The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (&lt;=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.51" spread="12.923"/>
                    <measurement group_id="O2" value="53.87" spread="17.594"/>
                    <measurement group_id="O3" value="50.07" spread="12.493"/>
                    <measurement group_id="O4" value="54.75" spread="16.380"/>
                    <measurement group_id="O5" value="54.78" spread="15.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="9.294"/>
                    <measurement group_id="O2" value="-5.80" spread="11.388"/>
                    <measurement group_id="O3" value="-8.16" spread="8.802"/>
                    <measurement group_id="O4" value="-2.55" spread="11.756"/>
                    <measurement group_id="O5" value="-3.52" spread="8.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment</title>
        <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment</title>
          <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.51" spread="12.923"/>
                    <measurement group_id="O2" value="53.87" spread="17.594"/>
                    <measurement group_id="O3" value="50.07" spread="12.493"/>
                    <measurement group_id="O4" value="54.75" spread="16.380"/>
                    <measurement group_id="O5" value="54.78" spread="15.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.52" spread="11.845"/>
                    <measurement group_id="O2" value="-6.91" spread="5.994"/>
                    <measurement group_id="O3" value="-4.95" spread="8.399"/>
                    <measurement group_id="O4" value="0.34" spread="14.194"/>
                    <measurement group_id="O5" value="-3.18" spread="8.971"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment</title>
        <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment</title>
          <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.51" spread="12.923"/>
                    <measurement group_id="O2" value="53.87" spread="17.594"/>
                    <measurement group_id="O3" value="50.07" spread="12.493"/>
                    <measurement group_id="O4" value="54.75" spread="16.380"/>
                    <measurement group_id="O5" value="54.78" spread="15.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.30" spread="18.512"/>
                    <measurement group_id="O2" value="-2.79" spread="7.541"/>
                    <measurement group_id="O3" value="-5.22" spread="11.974"/>
                    <measurement group_id="O4" value="0.36" spread="9.018"/>
                    <measurement group_id="O5" value="-4.92" spread="9.572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment</title>
        <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment</title>
          <description>The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number &lt;=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.51" spread="12.923"/>
                    <measurement group_id="O2" value="53.87" spread="17.594"/>
                    <measurement group_id="O3" value="50.07" spread="12.493"/>
                    <measurement group_id="O4" value="54.75" spread="16.380"/>
                    <measurement group_id="O5" value="54.78" spread="15.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.39" spread="19.383"/>
                    <measurement group_id="O2" value="-1.35" spread="8.821"/>
                    <measurement group_id="O3" value="-1.96" spread="8.459"/>
                    <measurement group_id="O4" value="-0.45" spread="13.389"/>
                    <measurement group_id="O5" value="-1.68" spread="12.683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1582</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-5.098</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.240</ci_lower_limit>
            <ci_upper_limit>2.045</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0961</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-6.105</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.332</ci_lower_limit>
            <ci_upper_limit>1.122</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8449</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.680</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.262</ci_lower_limit>
            <ci_upper_limit>7.623</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3747</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-3.140</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.178</ci_lower_limit>
            <ci_upper_limit>3.897</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment</title>
        <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment</title>
          <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.32" spread="6.625"/>
                    <measurement group_id="O2" value="20.40" spread="5.140"/>
                    <measurement group_id="O3" value="20.62" spread="5.898"/>
                    <measurement group_id="O4" value="21.89" spread="4.885"/>
                    <measurement group_id="O5" value="21.94" spread="7.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="5.078"/>
                    <measurement group_id="O2" value="-1.99" spread="2.825"/>
                    <measurement group_id="O3" value="-0.51" spread="6.522"/>
                    <measurement group_id="O4" value="-0.82" spread="5.722"/>
                    <measurement group_id="O5" value="1.54" spread="5.378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment</title>
        <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment</title>
          <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.32" spread="6.625"/>
                    <measurement group_id="O2" value="20.40" spread="5.140"/>
                    <measurement group_id="O3" value="20.62" spread="5.898"/>
                    <measurement group_id="O4" value="21.89" spread="4.885"/>
                    <measurement group_id="O5" value="21.94" spread="7.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="7.904"/>
                    <measurement group_id="O2" value="1.79" spread="12.957"/>
                    <measurement group_id="O3" value="4.71" spread="13.845"/>
                    <measurement group_id="O4" value="1.54" spread="6.333"/>
                    <measurement group_id="O5" value="2.57" spread="6.708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the aMeanDurWB During Week 3 of Treatment</title>
        <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the aMeanDurWB During Week 3 of Treatment</title>
          <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.32" spread="6.625"/>
                    <measurement group_id="O2" value="20.40" spread="5.140"/>
                    <measurement group_id="O3" value="20.62" spread="5.898"/>
                    <measurement group_id="O4" value="21.89" spread="4.885"/>
                    <measurement group_id="O5" value="21.94" spread="7.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.88" spread="7.928"/>
                    <measurement group_id="O2" value="3.67" spread="7.833"/>
                    <measurement group_id="O3" value="-0.52" spread="4.595"/>
                    <measurement group_id="O4" value="-0.64" spread="5.482"/>
                    <measurement group_id="O5" value="2.76" spread="7.489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the aMeanDurWB During Week 4 of Treatment</title>
        <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the aMeanDurWB During Week 4 of Treatment</title>
          <description>aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.32" spread="6.625"/>
                    <measurement group_id="O2" value="20.40" spread="5.140"/>
                    <measurement group_id="O3" value="20.62" spread="5.898"/>
                    <measurement group_id="O4" value="21.89" spread="4.885"/>
                    <measurement group_id="O5" value="21.94" spread="7.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="8.621"/>
                    <measurement group_id="O2" value="-0.43" spread="8.053"/>
                    <measurement group_id="O3" value="3.16" spread="8.140"/>
                    <measurement group_id="O4" value="-2.03" spread="4.947"/>
                    <measurement group_id="O5" value="3.38" spread="12.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3966</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>1.932</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.601</ci_lower_limit>
            <ci_upper_limit>6.465</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1381</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>3.386</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.125</ci_lower_limit>
            <ci_upper_limit>7.897</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5487</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>1.337</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.104</ci_lower_limit>
            <ci_upper_limit>5.778</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0581</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>4.320</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.153</ci_lower_limit>
            <ci_upper_limit>8.793</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment</title>
        <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment</title>
          <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of wake time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.74" spread="12.609"/>
                    <measurement group_id="O2" value="70.57" spread="11.669"/>
                    <measurement group_id="O3" value="72.53" spread="11.473"/>
                    <measurement group_id="O4" value="67.19" spread="11.523"/>
                    <measurement group_id="O5" value="70.67" spread="11.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="4.177"/>
                    <measurement group_id="O2" value="-2.41" spread="6.726"/>
                    <measurement group_id="O3" value="1.09" spread="6.793"/>
                    <measurement group_id="O4" value="-1.55" spread="9.216"/>
                    <measurement group_id="O5" value="-2.37" spread="8.779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean aWE During Week 2 of Treatment</title>
        <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean aWE During Week 2 of Treatment</title>
          <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of wake time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.74" spread="12.609"/>
                    <measurement group_id="O2" value="70.57" spread="11.669"/>
                    <measurement group_id="O3" value="72.53" spread="11.473"/>
                    <measurement group_id="O4" value="67.19" spread="11.523"/>
                    <measurement group_id="O5" value="70.67" spread="11.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="2.773"/>
                    <measurement group_id="O2" value="-1.54" spread="6.550"/>
                    <measurement group_id="O3" value="1.04" spread="7.511"/>
                    <measurement group_id="O4" value="-3.16" spread="12.816"/>
                    <measurement group_id="O5" value="-0.63" spread="5.617"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean aWE During Week 3 of Treatment</title>
        <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean aWE During Week 3 of Treatment</title>
          <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of wake time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.74" spread="12.609"/>
                    <measurement group_id="O2" value="70.57" spread="11.669"/>
                    <measurement group_id="O3" value="72.53" spread="11.473"/>
                    <measurement group_id="O4" value="67.19" spread="11.523"/>
                    <measurement group_id="O5" value="70.67" spread="11.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.64" spread="5.451"/>
                    <measurement group_id="O2" value="-2.37" spread="6.239"/>
                    <measurement group_id="O3" value="2.34" spread="8.370"/>
                    <measurement group_id="O4" value="-4.99" spread="11.479"/>
                    <measurement group_id="O5" value="-1.83" spread="5.579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean aWE During Week 4 of Treatment</title>
        <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean aWE During Week 4 of Treatment</title>
          <description>aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of wake time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.74" spread="12.609"/>
                    <measurement group_id="O2" value="70.57" spread="11.669"/>
                    <measurement group_id="O3" value="72.53" spread="11.473"/>
                    <measurement group_id="O4" value="67.19" spread="11.523"/>
                    <measurement group_id="O5" value="70.67" spread="11.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" spread="6.841"/>
                    <measurement group_id="O2" value="-2.29" spread="7.724"/>
                    <measurement group_id="O3" value="3.62" spread="8.586"/>
                    <measurement group_id="O4" value="-2.65" spread="9.627"/>
                    <measurement group_id="O5" value="-0.43" spread="5.848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1777</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-3.437</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.481</ci_lower_limit>
            <ci_upper_limit>1.608</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5630</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>1.458</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.564</ci_lower_limit>
            <ci_upper_limit>6.479</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0482</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-4.994</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.946</ci_lower_limit>
            <ci_upper_limit>-0.041</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3036</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-2.593</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.599</ci_lower_limit>
            <ci_upper_limit>2.413</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment</title>
        <description>The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment</title>
          <description>The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.43" spread="18.547"/>
                    <measurement group_id="O2" value="85.72" spread="16.137"/>
                    <measurement group_id="O3" value="86.53" spread="18.705"/>
                    <measurement group_id="O4" value="94.76" spread="17.262"/>
                    <measurement group_id="O5" value="87.96" spread="15.928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="6.968"/>
                    <measurement group_id="O2" value="4.22" spread="9.988"/>
                    <measurement group_id="O3" value="-2.18" spread="10.571"/>
                    <measurement group_id="O4" value="2.01" spread="13.017"/>
                    <measurement group_id="O5" value="3.25" spread="13.006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean WFI During Week 2 of Treatment</title>
        <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean WFI During Week 2 of Treatment</title>
          <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.43" spread="18.547"/>
                    <measurement group_id="O2" value="85.72" spread="16.137"/>
                    <measurement group_id="O3" value="86.53" spread="18.705"/>
                    <measurement group_id="O4" value="94.76" spread="17.262"/>
                    <measurement group_id="O5" value="87.96" spread="15.928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.76" spread="3.940"/>
                    <measurement group_id="O2" value="4.12" spread="8.671"/>
                    <measurement group_id="O3" value="-2.36" spread="11.453"/>
                    <measurement group_id="O4" value="5.09" spread="19.006"/>
                    <measurement group_id="O5" value="1.78" spread="9.271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean WFI During Week 3 of Treatment</title>
        <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean WFI During Week 3 of Treatment</title>
          <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.43" spread="18.547"/>
                    <measurement group_id="O2" value="85.72" spread="16.137"/>
                    <measurement group_id="O3" value="86.53" spread="18.705"/>
                    <measurement group_id="O4" value="94.76" spread="17.262"/>
                    <measurement group_id="O5" value="87.96" spread="15.928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="7.980"/>
                    <measurement group_id="O2" value="4.70" spread="9.674"/>
                    <measurement group_id="O3" value="-3.69" spread="13.236"/>
                    <measurement group_id="O4" value="6.88" spread="16.704"/>
                    <measurement group_id="O5" value="2.10" spread="8.631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean WFI During Week 4 of Treatment</title>
        <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean WFI During Week 4 of Treatment</title>
          <description>The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of &lt;=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>percentage of immobile bouts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.43" spread="18.547"/>
                    <measurement group_id="O2" value="85.72" spread="16.137"/>
                    <measurement group_id="O3" value="86.53" spread="18.705"/>
                    <measurement group_id="O4" value="94.76" spread="17.262"/>
                    <measurement group_id="O5" value="87.96" spread="15.928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.01" spread="10.620"/>
                    <measurement group_id="O2" value="4.55" spread="10.930"/>
                    <measurement group_id="O3" value="-6.93" spread="14.428"/>
                    <measurement group_id="O4" value="2.77" spread="13.407"/>
                    <measurement group_id="O5" value="1.22" spread="8.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1991</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>4.845</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.624</ci_lower_limit>
            <ci_upper_limit>12.313</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2982</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-3.872</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.263</ci_lower_limit>
            <ci_upper_limit>3.518</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0664</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>6.776</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.474</ci_lower_limit>
            <ci_upper_limit>14.025</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4148</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>3.017</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.344</ci_lower_limit>
            <ci_upper_limit>10.379</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the Mean Duration of Sleep Bouts (aMeanDurSB) During Week 1 of Treatment</title>
        <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Mean Duration of Sleep Bouts (aMeanDurSB) During Week 1 of Treatment</title>
          <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.36" spread="4.620"/>
                    <measurement group_id="O2" value="20.65" spread="3.638"/>
                    <measurement group_id="O3" value="23.13" spread="5.919"/>
                    <measurement group_id="O4" value="19.84" spread="3.364"/>
                    <measurement group_id="O5" value="23.30" spread="10.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="2.539"/>
                    <measurement group_id="O2" value="0.09" spread="4.056"/>
                    <measurement group_id="O3" value="-1.12" spread="5.202"/>
                    <measurement group_id="O4" value="-0.40" spread="3.394"/>
                    <measurement group_id="O5" value="-3.19" spread="10.405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the aMeanDurSB During Week 2 of Treatment</title>
        <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the aMeanDurSB During Week 2 of Treatment</title>
          <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.36" spread="4.620"/>
                    <measurement group_id="O2" value="20.65" spread="3.638"/>
                    <measurement group_id="O3" value="23.13" spread="5.919"/>
                    <measurement group_id="O4" value="19.84" spread="3.364"/>
                    <measurement group_id="O5" value="23.30" spread="10.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="2.999"/>
                    <measurement group_id="O2" value="-0.88" spread="4.679"/>
                    <measurement group_id="O3" value="-2.52" spread="5.965"/>
                    <measurement group_id="O4" value="-0.80" spread="2.961"/>
                    <measurement group_id="O5" value="-3.95" spread="8.980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the aMeanDurSB During Week 3 of Treatment</title>
        <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the aMeanDurSB During Week 3 of Treatment</title>
          <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.36" spread="4.620"/>
                    <measurement group_id="O2" value="20.65" spread="3.638"/>
                    <measurement group_id="O3" value="23.13" spread="5.919"/>
                    <measurement group_id="O4" value="19.84" spread="3.364"/>
                    <measurement group_id="O5" value="23.30" spread="10.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="3.249"/>
                    <measurement group_id="O2" value="-1.17" spread="4.056"/>
                    <measurement group_id="O3" value="-3.80" spread="3.701"/>
                    <measurement group_id="O4" value="-0.68" spread="2.292"/>
                    <measurement group_id="O5" value="-4.15" spread="10.264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the aMeanDurSB During Week 4 of Treatment</title>
        <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the aMeanDurSB During Week 4 of Treatment</title>
          <description>aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.36" spread="4.620"/>
                    <measurement group_id="O2" value="20.65" spread="3.638"/>
                    <measurement group_id="O3" value="23.13" spread="5.919"/>
                    <measurement group_id="O4" value="19.84" spread="3.364"/>
                    <measurement group_id="O5" value="23.30" spread="10.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="4.568"/>
                    <measurement group_id="O2" value="-1.31" spread="3.639"/>
                    <measurement group_id="O3" value="-2.80" spread="5.727"/>
                    <measurement group_id="O4" value="-0.03" spread="2.307"/>
                    <measurement group_id="O5" value="-5.30" spread="9.745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9599</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.063</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.452</ci_lower_limit>
            <ci_upper_limit>2.579</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8541</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.238</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.817</ci_lower_limit>
            <ci_upper_limit>2.342</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8117</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.293</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.745</ci_lower_limit>
            <ci_upper_limit>2.160</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2274</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-1.557</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.113</ci_lower_limit>
            <ci_upper_limit>1.000</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 1 of Treatment</title>
        <description>Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 1 of Treatment</title>
          <description>Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.262"/>
                    <measurement group_id="O2" value="0.90" spread="0.272"/>
                    <measurement group_id="O3" value="0.98" spread="0.295"/>
                    <measurement group_id="O4" value="1.10" spread="0.295"/>
                    <measurement group_id="O5" value="1.03" spread="0.330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.200"/>
                    <measurement group_id="O2" value="0.06" spread="0.218"/>
                    <measurement group_id="O3" value="-0.03" spread="0.237"/>
                    <measurement group_id="O4" value="0.10" spread="0.271"/>
                    <measurement group_id="O5" value="-0.01" spread="0.278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 2 of Treatment</title>
        <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 2 of Treatment</title>
          <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.262"/>
                    <measurement group_id="O2" value="0.90" spread="0.272"/>
                    <measurement group_id="O3" value="0.98" spread="0.295"/>
                    <measurement group_id="O4" value="1.10" spread="0.295"/>
                    <measurement group_id="O5" value="1.03" spread="0.330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.132"/>
                    <measurement group_id="O2" value="0.14" spread="0.325"/>
                    <measurement group_id="O3" value="0.02" spread="0.235"/>
                    <measurement group_id="O4" value="0.07" spread="0.143"/>
                    <measurement group_id="O5" value="0.05" spread="0.234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 3 of Treatment</title>
        <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 3 of Treatment</title>
          <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.262"/>
                    <measurement group_id="O2" value="0.90" spread="0.272"/>
                    <measurement group_id="O3" value="0.98" spread="0.295"/>
                    <measurement group_id="O4" value="1.10" spread="0.295"/>
                    <measurement group_id="O5" value="1.03" spread="0.330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.243"/>
                    <measurement group_id="O2" value="0.07" spread="0.246"/>
                    <measurement group_id="O3" value="-0.00" spread="0.241"/>
                    <measurement group_id="O4" value="-0.06" spread="0.311"/>
                    <measurement group_id="O5" value="-0.01" spread="0.219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 4 of Treatment</title>
        <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 4 of Treatment</title>
          <description>Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="0.262"/>
                    <measurement group_id="O2" value="0.90" spread="0.272"/>
                    <measurement group_id="O3" value="0.98" spread="0.295"/>
                    <measurement group_id="O4" value="1.10" spread="0.295"/>
                    <measurement group_id="O5" value="1.03" spread="0.330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.324"/>
                    <measurement group_id="O2" value="0.10" spread="0.196"/>
                    <measurement group_id="O3" value="0.02" spread="0.157"/>
                    <measurement group_id="O4" value="-0.12" spread="0.274"/>
                    <measurement group_id="O5" value="-0.10" spread="0.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2421</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.086</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.060</ci_lower_limit>
            <ci_upper_limit>0.232</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8661</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.012</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.155</ci_lower_limit>
            <ci_upper_limit>0.131</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4251</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.057</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.085</ci_lower_limit>
            <ci_upper_limit>0.199</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7248</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.025</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.116</ci_lower_limit>
            <ci_upper_limit>0.166</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean Interdaily Stability (IS) Over Week 1 of Treatment</title>
        <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean Interdaily Stability (IS) Over Week 1 of Treatment</title>
          <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.173"/>
                    <measurement group_id="O2" value="0.47" spread="0.111"/>
                    <measurement group_id="O3" value="0.49" spread="0.118"/>
                    <measurement group_id="O4" value="0.46" spread="0.160"/>
                    <measurement group_id="O5" value="0.41" spread="0.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.083"/>
                    <measurement group_id="O2" value="-0.02" spread="0.089"/>
                    <measurement group_id="O3" value="0.04" spread="0.115"/>
                    <measurement group_id="O4" value="-0.00" spread="0.155"/>
                    <measurement group_id="O5" value="0.06" spread="0.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean IS Over Week 2 of Treatment</title>
        <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean IS Over Week 2 of Treatment</title>
          <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.173"/>
                    <measurement group_id="O2" value="0.47" spread="0.111"/>
                    <measurement group_id="O3" value="0.49" spread="0.118"/>
                    <measurement group_id="O4" value="0.46" spread="0.160"/>
                    <measurement group_id="O5" value="0.41" spread="0.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.093"/>
                    <measurement group_id="O2" value="-0.01" spread="0.101"/>
                    <measurement group_id="O3" value="0.03" spread="0.133"/>
                    <measurement group_id="O4" value="-0.06" spread="0.091"/>
                    <measurement group_id="O5" value="0.09" spread="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean IS Over Week 3 of Treatment</title>
        <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean IS Over Week 3 of Treatment</title>
          <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.173"/>
                    <measurement group_id="O2" value="0.47" spread="0.111"/>
                    <measurement group_id="O3" value="0.49" spread="0.118"/>
                    <measurement group_id="O4" value="0.46" spread="0.160"/>
                    <measurement group_id="O5" value="0.41" spread="0.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.104"/>
                    <measurement group_id="O2" value="-0.01" spread="0.107"/>
                    <measurement group_id="O3" value="0.03" spread="0.115"/>
                    <measurement group_id="O4" value="-0.04" spread="0.136"/>
                    <measurement group_id="O5" value="0.04" spread="0.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Mean IS Over Week 4 of Treatment</title>
        <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Mean IS Over Week 4 of Treatment</title>
          <description>IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.173"/>
                    <measurement group_id="O2" value="0.47" spread="0.111"/>
                    <measurement group_id="O3" value="0.49" spread="0.118"/>
                    <measurement group_id="O4" value="0.46" spread="0.160"/>
                    <measurement group_id="O5" value="0.41" spread="0.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.098"/>
                    <measurement group_id="O2" value="0.01" spread="0.119"/>
                    <measurement group_id="O3" value="0.08" spread="0.092"/>
                    <measurement group_id="O4" value="0.03" spread="0.127"/>
                    <measurement group_id="O5" value="0.00" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2991</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.032</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.094</ci_lower_limit>
            <ci_upper_limit>0.029</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2861</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.033</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.028</ci_lower_limit>
            <ci_upper_limit>0.095</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0938</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-0.052</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.113</ci_lower_limit>
            <ci_upper_limit>0.009</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8618</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.005</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.055</ci_lower_limit>
            <ci_upper_limit>0.066</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Average Activity Counts Across Least Active 5-hour Period (L5) Per 24-Hour Period Over Week 1 of Treatment</title>
        <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Average Activity Counts Across Least Active 5-hour Period (L5) Per 24-Hour Period Over Week 1 of Treatment</title>
          <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1163.5" spread="373.3"/>
                    <measurement group_id="O2" value="1266.4" spread="678.1"/>
                    <measurement group_id="O3" value="1163.2" spread="591.8"/>
                    <measurement group_id="O4" value="1257.1" spread="836.6"/>
                    <measurement group_id="O5" value="1490.4" spread="963.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200.9" spread="633.3"/>
                    <measurement group_id="O2" value="-259.8" spread="450.3"/>
                    <measurement group_id="O3" value="-243.2" spread="333.6"/>
                    <measurement group_id="O4" value="-211.6" spread="378.3"/>
                    <measurement group_id="O5" value="-434.2" spread="509.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 2 of Treatment</title>
        <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 2 of Treatment</title>
          <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1163.5" spread="373.3"/>
                    <measurement group_id="O2" value="1266.4" spread="678.1"/>
                    <measurement group_id="O3" value="1163.2" spread="591.8"/>
                    <measurement group_id="O4" value="1257.1" spread="836.6"/>
                    <measurement group_id="O5" value="1490.4" spread="963.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.8" spread="525.3"/>
                    <measurement group_id="O2" value="-259.8" spread="244.9"/>
                    <measurement group_id="O3" value="-218.7" spread="321.6"/>
                    <measurement group_id="O4" value="218.5" spread="455.9"/>
                    <measurement group_id="O5" value="-246.1" spread="637.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 3 of Treatment</title>
        <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 3 of Treatment</title>
          <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1163.5" spread="373.3"/>
                    <measurement group_id="O2" value="1266.4" spread="678.1"/>
                    <measurement group_id="O3" value="1163.2" spread="591.8"/>
                    <measurement group_id="O4" value="1257.1" spread="836.6"/>
                    <measurement group_id="O5" value="1490.4" spread="963.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299.2" spread="1070.2"/>
                    <measurement group_id="O2" value="-265.3" spread="507.0"/>
                    <measurement group_id="O3" value="-233.0" spread="369.3"/>
                    <measurement group_id="O4" value="-114.6" spread="376.6"/>
                    <measurement group_id="O5" value="-396.1" spread="543.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 4 of Treatment</title>
        <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 4 of Treatment</title>
          <description>L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1163.5" spread="373.3"/>
                    <measurement group_id="O2" value="1266.4" spread="678.1"/>
                    <measurement group_id="O3" value="1163.2" spread="591.8"/>
                    <measurement group_id="O4" value="1257.1" spread="836.6"/>
                    <measurement group_id="O5" value="1490.4" spread="963.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="293.1" spread="662.6"/>
                    <measurement group_id="O2" value="-334.0" spread="476.4"/>
                    <measurement group_id="O3" value="-344.5" spread="419.1"/>
                    <measurement group_id="O4" value="30.5" spread="772.5"/>
                    <measurement group_id="O5" value="-160.7" spread="471.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0294</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-389.873</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-739.177</ci_lower_limit>
            <ci_upper_limit>-40.569</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0243</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-402.994</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-751.670</ci_lower_limit>
            <ci_upper_limit>-54.319</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4209</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-141.026</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-489.805</ci_lower_limit>
            <ci_upper_limit>207.752</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0398</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-367.845</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-717.870</ci_lower_limit>
            <ci_upper_limit>-17.820</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the Average Activity Count During the Most Active 10-hour Period (M10) Per 24-Hour Period Over Week 1 of Treatment</title>
        <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Average Activity Count During the Most Active 10-hour Period (M10) Per 24-Hour Period Over Week 1 of Treatment</title>
          <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8560.4" spread="2631.2"/>
                    <measurement group_id="O2" value="11567.0" spread="4266.3"/>
                    <measurement group_id="O3" value="12158.1" spread="3639.9"/>
                    <measurement group_id="O4" value="10662.1" spread="5023.6"/>
                    <measurement group_id="O5" value="11460.5" spread="4954.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" spread="1832.6"/>
                    <measurement group_id="O2" value="-731.4" spread="3373.5"/>
                    <measurement group_id="O3" value="42.5" spread="1789.3"/>
                    <measurement group_id="O4" value="-334.6" spread="2659.2"/>
                    <measurement group_id="O5" value="-111.2" spread="2558.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 2 of Treatment</title>
        <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 2 of Treatment</title>
          <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8560.4" spread="2631.2"/>
                    <measurement group_id="O2" value="11567.0" spread="4266.3"/>
                    <measurement group_id="O3" value="12158.1" spread="3639.9"/>
                    <measurement group_id="O4" value="10662.1" spread="5023.6"/>
                    <measurement group_id="O5" value="11460.5" spread="4954.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232.7" spread="1829.1"/>
                    <measurement group_id="O2" value="-968.8" spread="2885.6"/>
                    <measurement group_id="O3" value="-121.1" spread="2137.3"/>
                    <measurement group_id="O4" value="-564.2" spread="1975.7"/>
                    <measurement group_id="O5" value="-325.4" spread="1585.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 3 of Treatment</title>
        <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 3 of Treatment</title>
          <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8560.4" spread="2631.2"/>
                    <measurement group_id="O2" value="11567.0" spread="4266.3"/>
                    <measurement group_id="O3" value="12158.1" spread="3639.9"/>
                    <measurement group_id="O4" value="10662.1" spread="5023.6"/>
                    <measurement group_id="O5" value="11460.5" spread="4954.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="300.3" spread="2094.9"/>
                    <measurement group_id="O2" value="-986.2" spread="3502.0"/>
                    <measurement group_id="O3" value="572.6" spread="2216.0"/>
                    <measurement group_id="O4" value="-828.3" spread="1970.2"/>
                    <measurement group_id="O5" value="-635.8" spread="2413.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 4 of Treatment</title>
        <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 4 of Treatment</title>
          <description>M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8560.4" spread="2631.2"/>
                    <measurement group_id="O2" value="11567.0" spread="4266.3"/>
                    <measurement group_id="O3" value="12158.1" spread="3639.9"/>
                    <measurement group_id="O4" value="10662.1" spread="5023.6"/>
                    <measurement group_id="O5" value="11460.5" spread="4954.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1650.4" spread="1815.3"/>
                    <measurement group_id="O2" value="-1392.1" spread="2249.3"/>
                    <measurement group_id="O3" value="-477.4" spread="963.2"/>
                    <measurement group_id="O4" value="279.8" spread="2204.0"/>
                    <measurement group_id="O5" value="-457.8" spread="1788.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1162</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-1276.180</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2878.587</ci_lower_limit>
            <ci_upper_limit>326.226</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7781</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>227.464</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1382.850</ci_lower_limit>
            <ci_upper_limit>1837.777</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4255</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-620.581</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2170.342</ci_lower_limit>
            <ci_upper_limit>929.179</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4672</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-577.820</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2160.337</ci_lower_limit>
            <ci_upper_limit>1004.697</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Amplitude of the Rest-activity Rhythm (AMP) Over Week 1 of Treatment</title>
        <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Amplitude of the Rest-activity Rhythm (AMP) Over Week 1 of Treatment</title>
          <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7396.9" spread="2728.3"/>
                    <measurement group_id="O2" value="10300.6" spread="4235.8"/>
                    <measurement group_id="O3" value="10994.8" spread="3601.8"/>
                    <measurement group_id="O4" value="9405.0" spread="5133.9"/>
                    <measurement group_id="O5" value="9970.0" spread="4905.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-141.1" spread="1583.8"/>
                    <measurement group_id="O2" value="-471.6" spread="3414.4"/>
                    <measurement group_id="O3" value="285.8" spread="1788.6"/>
                    <measurement group_id="O4" value="-123.0" spread="2784.1"/>
                    <measurement group_id="O5" value="323.0" spread="2436.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in AMP Over Week 2 of Treatment</title>
        <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in AMP Over Week 2 of Treatment</title>
          <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7396.9" spread="2728.3"/>
                    <measurement group_id="O2" value="10300.6" spread="4235.8"/>
                    <measurement group_id="O3" value="10994.8" spread="3601.8"/>
                    <measurement group_id="O4" value="9405.0" spread="5133.9"/>
                    <measurement group_id="O5" value="9970.0" spread="4905.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.8" spread="1603.7"/>
                    <measurement group_id="O2" value="-708.9" spread="2934.6"/>
                    <measurement group_id="O3" value="97.6" spread="2105.2"/>
                    <measurement group_id="O4" value="-782.7" spread="2141.4"/>
                    <measurement group_id="O5" value="-79.3" spread="1672.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in AMP Over Week 3 of Treatment</title>
        <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in AMP Over Week 3 of Treatment</title>
          <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7396.9" spread="2728.3"/>
                    <measurement group_id="O2" value="10300.6" spread="4235.8"/>
                    <measurement group_id="O3" value="10994.8" spread="3601.8"/>
                    <measurement group_id="O4" value="9405.0" spread="5133.9"/>
                    <measurement group_id="O5" value="9970.0" spread="4905.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1862.7"/>
                    <measurement group_id="O2" value="-721.0" spread="3502.2"/>
                    <measurement group_id="O3" value="805.6" spread="2195.6"/>
                    <measurement group_id="O4" value="-713.7" spread="2178.3"/>
                    <measurement group_id="O5" value="-239.7" spread="2592.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in AMP Over Week 4 of Treatment</title>
        <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in AMP Over Week 4 of Treatment</title>
          <description>AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>activity count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7396.9" spread="2728.3"/>
                    <measurement group_id="O2" value="10300.6" spread="4235.8"/>
                    <measurement group_id="O3" value="10994.8" spread="3601.8"/>
                    <measurement group_id="O4" value="9405.0" spread="5133.9"/>
                    <measurement group_id="O5" value="9970.0" spread="4905.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1357.3" spread="1801.9"/>
                    <measurement group_id="O2" value="-1058.0" spread="2170.9"/>
                    <measurement group_id="O3" value="-132.9" spread="840.7"/>
                    <measurement group_id="O4" value="249.4" spread="2694.7"/>
                    <measurement group_id="O5" value="-297.1" spread="1608.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2984</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-839.088</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2440.854</ci_lower_limit>
            <ci_upper_limit>762.678</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4218</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>651.922</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-962.835</ci_lower_limit>
            <ci_upper_limit>2266.678</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5655</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-447.245</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1998.440</ci_lower_limit>
            <ci_upper_limit>1103.950</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8686</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>-130.603</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1706.478</ci_lower_limit>
            <ci_upper_limit>1445.272</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in Relative Amplitude in the Rest-activity Rhythm (RA) Over Week 1 of Treatment</title>
        <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 1</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in Relative Amplitude in the Rest-activity Rhythm (RA) Over Week 1 of Treatment</title>
          <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.136"/>
                    <measurement group_id="O2" value="0.79" spread="0.141"/>
                    <measurement group_id="O3" value="0.82" spread="0.089"/>
                    <measurement group_id="O4" value="0.77" spread="0.165"/>
                    <measurement group_id="O5" value="0.76" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.101"/>
                    <measurement group_id="O2" value="0.01" spread="0.080"/>
                    <measurement group_id="O3" value="0.03" spread="0.067"/>
                    <measurement group_id="O4" value="0.02" spread="0.096"/>
                    <measurement group_id="O5" value="0.07" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in RA Over Week 2 of Treatment</title>
        <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 2</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in RA Over Week 2 of Treatment</title>
          <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.136"/>
                    <measurement group_id="O2" value="0.79" spread="0.141"/>
                    <measurement group_id="O3" value="0.82" spread="0.089"/>
                    <measurement group_id="O4" value="0.77" spread="0.165"/>
                    <measurement group_id="O5" value="0.76" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.00" spread="0.073"/>
                    <measurement group_id="O2" value="0.01" spread="0.063"/>
                    <measurement group_id="O3" value="0.03" spread="0.052"/>
                    <measurement group_id="O4" value="-0.05" spread="0.112"/>
                    <measurement group_id="O5" value="0.05" spread="0.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in RA Over Week 3 of Treatment</title>
        <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 3</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in RA Over Week 3 of Treatment</title>
          <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.136"/>
                    <measurement group_id="O2" value="0.79" spread="0.141"/>
                    <measurement group_id="O3" value="0.82" spread="0.089"/>
                    <measurement group_id="O4" value="0.77" spread="0.165"/>
                    <measurement group_id="O5" value="0.76" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.143"/>
                    <measurement group_id="O2" value="0.01" spread="0.088"/>
                    <measurement group_id="O3" value="0.04" spread="0.063"/>
                    <measurement group_id="O4" value="0.01" spread="0.090"/>
                    <measurement group_id="O5" value="0.06" spread="0.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Core Phase: Change From Baseline in RA Over Week 4 of Treatment</title>
        <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in RA Over Week 4 of Treatment</title>
          <description>RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.136"/>
                    <measurement group_id="O2" value="0.79" spread="0.141"/>
                    <measurement group_id="O3" value="0.82" spread="0.089"/>
                    <measurement group_id="O4" value="0.77" spread="0.165"/>
                    <measurement group_id="O5" value="0.76" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.00" spread="0.117"/>
                    <measurement group_id="O2" value="0.01" spread="0.060"/>
                    <measurement group_id="O3" value="0.05" spread="0.049"/>
                    <measurement group_id="O4" value="0.01" spread="0.136"/>
                    <measurement group_id="O5" value="0.02" spread="0.069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4638</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.020</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.034</ci_lower_limit>
            <ci_upper_limit>0.074</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0322</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.060</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.005</ci_lower_limit>
            <ci_upper_limit>0.115</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9144</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.003</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.051</ci_lower_limit>
            <ci_upper_limit>0.056</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0364</p_value>
            <p_value_desc>Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction</p_value_desc>
            <method>MMRM</method>
            <param_type>LSM Difference</param_type>
            <param_value>0.057</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.004</ci_lower_limit>
            <ci_upper_limit>0.110</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <time_frame>First dose of study drug (Day 1) to 14 days after last dose of study drug (approximately up to 2 years 7 months)</time_frame>
        <population>The safety analysis set included the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O6">
            <title>Extension Phase: Lemborexant 5 mg</title>
            <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
          </group>
          <group group_id="O7">
            <title>Extension Phase: Lemborexant 10 mg</title>
            <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
          </group>
          <group group_id="O8">
            <title>Extension Phase: Lemborexant 15 mg</title>
            <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <population>The safety analysis set included the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="14"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Core Phase: Number of Participants in Each Category With Clinician's Global Impression of Change-Irregular Sleep-Wake Rhythm Disorder (CGIC-ISWRD) Global Score at Day 29</title>
        <description>The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 [marked improvement] to 7 [marked worsening]).</description>
        <time_frame>Day 29</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Number of Participants in Each Category With Clinician's Global Impression of Change-Irregular Sleep-Wake Rhythm Disorder (CGIC-ISWRD) Global Score at Day 29</title>
          <description>The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 [marked improvement] to 7 [marked worsening]).</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement.</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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global score: Marked improvement</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global score: Moderate improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global score: Minimal improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global score: No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global score: Minimal worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global score : Moderate worsening</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global score : Marked worsening</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Core Phase: Change From Baseline in the Neuropsychiatric Inventory (NPI-10) Total Score at Day 29</title>
        <description>The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) * Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.</description>
        <time_frame>Baseline, Day 29</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Neuropsychiatric Inventory (NPI-10) Total Score at Day 29</title>
          <description>The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) * Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>score 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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="4.13"/>
                    <measurement group_id="O2" value="13.1" spread="17.77"/>
                    <measurement group_id="O3" value="7.7" spread="12.32"/>
                    <measurement group_id="O4" value="6.4" spread="10.27"/>
                    <measurement group_id="O5" value="5.5" spread="5.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="3.64"/>
                    <measurement group_id="O2" value="-3.4" spread="9.23"/>
                    <measurement group_id="O3" value="-0.3" spread="5.85"/>
                    <measurement group_id="O4" value="-3.4" spread="8.95"/>
                    <measurement group_id="O5" value="3.8" spread="13.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Core Phase: Change From Baseline in the Sleep Disorders Inventory (SDI) Score at Day 29</title>
        <description>The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).</description>
        <time_frame>Baseline, Day 29</time_frame>
        <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Phase: Lemborexant-matched Placebo</title>
            <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Core Phase: Lemborexant 2.5 mg</title>
            <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Core Phase: Lemborexant 5 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Core Phase: Lemborexant 10 mg</title>
            <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Core Phase: Lemborexant 15 mg</title>
            <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Phase: Change From Baseline in the Sleep Disorders Inventory (SDI) Score at Day 29</title>
          <description>The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).</description>
          <population>The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.</population>
          <units>score 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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="0.692"/>
                    <measurement group_id="O2" value="1.24" spread="1.576"/>
                    <measurement group_id="O3" value="0.74" spread="0.653"/>
                    <measurement group_id="O4" value="0.66" spread="0.748"/>
                    <measurement group_id="O5" value="1.44" spread="1.708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="1.078"/>
                    <measurement group_id="O2" value="-0.10" spread="0.616"/>
                    <measurement group_id="O3" value="-0.33" spread="0.503"/>
                    <measurement group_id="O4" value="-0.09" spread="0.574"/>
                    <measurement group_id="O5" value="-0.49" spread="1.220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Extension Phase: Change From Baseline in SDI Total Score.</title>
        <description>The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).</description>
        <time_frame>Baseline, Day 133, 223, 313, 343, 373, 403, 493, 583, 673, and 763</time_frame>
        <population>The safety analysis set included the group of extension phase participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment in extension phase. Here overall number analyzed &quot;N&quot; are the participants who were evaluable for the outcome measure. Number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure for given categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Extension Phase: Lemborexant 5 mg</title>
            <description>Participants who completed the core study end of study (EOS) visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for Irregular Sleep-Wake Rhythm Disorder (ISWRD) is discontinued or up to 30 months.</description>
          </group>
          <group group_id="O2">
            <title>Extension Phase: Lemborexant 10 mg</title>
            <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
          </group>
          <group group_id="O3">
            <title>Extension Phase: Lemborexant 15 mg</title>
            <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Extension Phase: Change From Baseline in SDI Total Score.</title>
          <description>The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).</description>
          <population>The safety analysis set included the group of extension phase participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment in extension phase. Here overall number analyzed &quot;N&quot; are the participants who were evaluable for the outcome measure. Number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure for given categories.</population>
          <units>score 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="5"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" spread="1.948"/>
                    <measurement group_id="O2" value="0.74" spread="0.728"/>
                    <measurement group_id="O3" value="1.45" spread="2.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 133 (Visit 9)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40"/>
                    <measurement group_id="O2" value="-0.45" spread="0.600"/>
                    <measurement group_id="O3" value="-0.63" spread="0.473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 223 (Visit 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.60" spread="0.693"/>
                    <measurement group_id="O3" value="0.17" spread="0.306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 313 (Visit 15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.65" spread="0.574"/>
                    <measurement group_id="O3" value="-0.17" spread="1.266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 343 (Visit 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60"/>
                    <measurement group_id="O2" value="0.55" spread="1.061"/>
                    <measurement group_id="O3" value="0.45" spread="0.919"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 373 (Visit 17)</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="-0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 403 (Visit 18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.50" spread="0.539"/>
                    <measurement group_id="O3" value="-0.55" spread="0.656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 493 (Visit 19)</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="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.13" spread="0.115"/>
                    <measurement group_id="O3" value="-0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 583 (Visit 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="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.15" spread="0.071"/>
                    <measurement group_id="O3" value="-0.35" spread="0.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 673 (Visit 21)</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="-0.30"/>
                    <measurement group_id="O3" value="-0.15" spread="0.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 763 (Visit 22)</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="-0.05" spread="0.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First dose of study drug (Day 1) to 14 days after last dose of study drug (approximately up to 2 years 7 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Core Phase: Lemborexant-matched Placebo</title>
          <description>Participants received two lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Core Phase: Lemborexant 2.5 mg</title>
          <description>Participants received one lemborexant 2.5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="E3">
          <title>Core Phase: Lemborexant 5 mg</title>
          <description>Participants received one lemborexant 5 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="E4">
          <title>Core Phase: Lemborexant 10 mg</title>
          <description>Participants received one lemborexant 10 mg and one lemborexant-matched placebo, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="E5">
          <title>Core Phase: Lemborexant 15 mg</title>
          <description>Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night for 28 consecutive nights in 4-week treatment period.</description>
        </group>
        <group group_id="E6">
          <title>Extension Phase: Lemborexant 5 mg</title>
          <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
        </group>
        <group group_id="E7">
          <title>Extension Phase: Lemborexant 10 mg</title>
          <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 10 mg, tablet, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
        </group>
        <group group_id="E8">
          <title>Extension Phase: Lemborexant 15 mg</title>
          <description>Participants who completed the core study EOS visit within 30 days prior to enrollment in extension phase were eligible to participate in extension phase. Participants received one lemborexant 5 mg and one lemborexant 10 mg, tablets, orally, once daily, immediately (within 5 minutes) before the bedtime at night until lemborexant is commercially available, or until the lemborexant clinical development program for ISWRD is discontinued or up to 30 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ilium fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Genital injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Libido increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Genital discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eisai Medical Information</name_or_title>
      <organization>Eisai Inc.</organization>
      <phone>1-888-274-2378</phone>
      <email>esi_medinfo@eisai.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/NCT03001557
org study id: E2006-G000-202
secondary id: 2017-003306-40
nct id: NCT03001557
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will be conducted to determine the dose response of lemborexant (LEM) on the
      change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters,
      and circadian-rhythm related parameters. Following the eligibility screening period, eligible
      participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks.
      After a 2-week follow-up period, eligible participants may enter an open-label extension
      period for up to 30 months or until the program discontinuation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment
time frame: Baseline, Week 1
description: aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment
time frame: Baseline, Week 2
description: aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment
time frame: Baseline, Week 3
description: aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment
time frame: Baseline, Week 4
description: aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment
time frame: Baseline, Week 1
description: The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (<=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment
time frame: Baseline, Week 2
description: The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number <=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment
time frame: Baseline, Week 3
description: The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number <=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment
time frame: Baseline, Week 4
description: The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number <=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment
time frame: Baseline, Week 1
description: aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment
time frame: Baseline, Week 2
description: aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the aMeanDurWB During Week 3 of Treatment
time frame: Baseline, Week 3
description: aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the aMeanDurWB During Week 4 of Treatment
time frame: Baseline, Week 4
description: aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment
time frame: Baseline, Week 1
description: aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean aWE During Week 2 of Treatment
time frame: Baseline, Week 2
description: aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean aWE During Week 3 of Treatment
time frame: Baseline, Week 3
description: aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean aWE During Week 4 of Treatment
time frame: Baseline, Week 4
description: aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment
time frame: Baseline, Week 1
description: The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean WFI During Week 2 of Treatment
time frame: Baseline, Week 2
description: The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean WFI During Week 3 of Treatment
time frame: Baseline, Week 3
description: The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean WFI During Week 4 of Treatment
time frame: Baseline, Week 4
description: The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the Mean Duration of Sleep Bouts (aMeanDurSB) During Week 1 of Treatment
time frame: Baseline, Week 1
description: aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the aMeanDurSB During Week 2 of Treatment
time frame: Baseline, Week 2
description: aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the aMeanDurSB During Week 3 of Treatment
time frame: Baseline, Week 3
description: aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the aMeanDurSB During Week 4 of Treatment
time frame: Baseline, Week 4
description: aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 1 of Treatment
time frame: Baseline, Week 1
description: Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 2 of Treatment
time frame: Baseline, Week 2
description: Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 3 of Treatment
time frame: Baseline, Week 3
description: Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 4 of Treatment
time frame: Baseline, Week 4
description: Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean Interdaily Stability (IS) Over Week 1 of Treatment
time frame: Baseline, Week 1
description: IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean IS Over Week 2 of Treatment
time frame: Baseline, Week 2
description: IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean IS Over Week 3 of Treatment
time frame: Baseline, Week 3
description: IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Mean IS Over Week 4 of Treatment
time frame: Baseline, Week 4
description: IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Average Activity Counts Across Least Active 5-hour Period (L5) Per 24-Hour Period Over Week 1 of Treatment
time frame: Baseline, Week 1
description: L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 2 of Treatment
time frame: Baseline, Week 2
description: L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 3 of Treatment
time frame: Baseline, Week 3
description: L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 4 of Treatment
time frame: Baseline, Week 4
description: L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the Average Activity Count During the Most Active 10-hour Period (M10) Per 24-Hour Period Over Week 1 of Treatment
time frame: Baseline, Week 1
description: M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 2 of Treatment
time frame: Baseline, Week 2
description: M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 3 of Treatment
time frame: Baseline, Week 3
description: M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 4 of Treatment
time frame: Baseline, Week 4
description: M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Amplitude of the Rest-activity Rhythm (AMP) Over Week 1 of Treatment
time frame: Baseline, Week 1
description: AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in AMP Over Week 2 of Treatment
time frame: Baseline, Week 2
description: AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in AMP Over Week 3 of Treatment
time frame: Baseline, Week 3
description: AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in AMP Over Week 4 of Treatment
time frame: Baseline, Week 4
description: AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in Relative Amplitude in the Rest-activity Rhythm (RA) Over Week 1 of Treatment
time frame: Baseline, Week 1
description: RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in RA Over Week 2 of Treatment
time frame: Baseline, Week 2
description: RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in RA Over Week 3 of Treatment
time frame: Baseline, Week 3
description: RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
measure: Core Phase: Change From Baseline in RA Over Week 4 of Treatment
time frame: Baseline, Week 4
description: RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: First dose of study drug (Day 1) to 14 days after last dose of study drug (approximately up to 2 years 7 months)
measure: Core Phase: Number of Participants in Each Category With Clinician's Global Impression of Change-Irregular Sleep-Wake Rhythm Disorder (CGIC-ISWRD) Global Score at Day 29
time frame: Day 29
description: The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 [marked improvement] to 7 [marked worsening]).
measure: Core Phase: Change From Baseline in the Neuropsychiatric Inventory (NPI-10) Total Score at Day 29
time frame: Baseline, Day 29
description: The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) * Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.
measure: Core Phase: Change From Baseline in the Sleep Disorders Inventory (SDI) Score at Day 29
time frame: Baseline, Day 29
description: The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).
measure: Extension Phase: Change From Baseline in SDI Total Score.
time frame: Baseline, Day 133, 223, 313, 343, 373, 403, 493, 583, 673, and 763
description: The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).
arm group label: Lemborexant 2.5 milligrams (mg)
arm group type: Experimental
description: Participants will take one lemborexant 2.5 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
arm group label: Lemborexant 5 mg
arm group type: Experimental
description: Participants will take one lemborexant 5 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
arm group label: Lemborexant 10 mg
arm group type: Experimental
description: Participants will take one lemborexant 10 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
arm group label: Lemborexant 15 mg
arm group type: Experimental
description: Participants will take one lemborexant 5 mg tablet and one lemborexant 10 mg tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
arm group label: Lemborexant-matched placebo
arm group type: Placebo Comparator
description: Participants will take two lemborexant-matched placebo tablets orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
intervention type: Drug
intervention name: Lemborexant 2.5 mg
description: Lemborexant 2.5 mg tablets
arm group label: Lemborexant 2.5 milligrams (mg)
intervention type: Drug
intervention name: Lemborexant 5 mg
description: Lemborexant 5 mg tablets
arm group label: Lemborexant 5 mg
intervention type: Drug
intervention name: Lemborexant 10 mg
description: Lemborexant 10 mg tablets
arm group label: Lemborexant 10 mg
arm group label: Lemborexant 15 mg
intervention type: Drug
intervention name: Lemborexant 15 mg
description: Lemborexant 5 mg and 10 mg tablets
arm group label: Lemborexant 15 mg
intervention type: Drug
intervention name: Lemborexant-matched placebo
description: Lemborexant-matched placebo tablets
arm group label: Lemborexant 10 mg
arm group label: Lemborexant 2.5 milligrams (mg)
arm group label: Lemborexant 5 mg
arm group label: Lemborexant-matched placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
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country: Japan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Lemborexant
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