Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study A
Brief Summary: This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.


Options:
A: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 (Baseline and Month 3); Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase (Up to 3 months); Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase (Up to 3 months)
B: Change from Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)
C: Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase (From the first day of study treatment up to 12 months)
D: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)

Answer: A