{"protocolSection":{"identificationModule":{"nctId":"NCT05071612","orgStudyIdInfo":{"id":"MARIPOSA"},"organization":{"fullName":"Apnimed","class":"INDUSTRY"},"briefTitle":"Parallel Arm Trial of AD109 and AD504 In Patients With OSA","officialTitle":"Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea","acronym":"MARIPOSA"},"statusModule":{"statusVerifiedDate":"2026-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-11-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-07-20","type":"ACTUAL"},"completionDateStruct":{"date":"2022-08-03","type":"ACTUAL"},"studyFirstSubmitDate":"2021-09-27","studyFirstSubmitQcDate":"2021-09-28","studyFirstPostDateStruct":{"date":"2021-10-08","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-06-04","resultsFirstSubmitQcDate":"2026-08-07","resultsFirstPostDateStruct":{"date":"2026-08-12","type":"ACTUAL"},"dispFirstSubmitDate":"2022-11-30","dispFirstPostDateStruct":{"date":"2026-08-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-08-07","lastUpdatePostDateStruct":{"date":"2026-08-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Apnimed","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea."},"conditionsModule":{"conditions":["OSA - Obstructive Sleep Apnea"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":294,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"AD109 75/5mg","type":"EXPERIMENTAL","description":"Atomoxetine 75 mg/Aroxybutynin 5 mg tablet","interventionNames":["Drug: AD109"]},{"label":"AD109 75/2.5mg","type":"EXPERIMENTAL","description":"Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet","interventionNames":["Drug: AD109"]},{"label":"AD504 75/100mg","type":"EXPERIMENTAL","description":"Atomoxetine 75 mg tablet/Trazodone 100 mg capsule","interventionNames":["Drug: AD504"]},{"label":"AD504 75/50mg","type":"EXPERIMENTAL","description":"Atomoxetine 75 mg tablet/Trazodone 50 mg capsule","interventionNames":["Drug: AD504"]},{"label":"Atomoxetine 75mg","type":"ACTIVE_COMPARATOR","description":"Atomoxetine 75 mg tablet","interventionNames":["Drug: Atomoxetine Hydrochloride"]},{"label":"Atomoxetine 75mg plus placebo","type":"ACTIVE_COMPARATOR","description":"Atomoxetine 75 mg tablet/placebo capsule","interventionNames":["Drug: Atomoxetine Hydrochloride"]},{"label":"Placebo tablet","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Placebo tablet plus placebo capsule","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"AD109","description":"Oral administration at bedtime","armGroupLabels":["AD109 75/2.5mg","AD109 75/5mg"]},{"type":"DRUG","name":"AD504","description":"Oral administration at bedtime","armGroupLabels":["AD504 75/100mg","AD504 75/50mg"]},{"type":"DRUG","name":"Atomoxetine Hydrochloride","description":"Oral administration at bedtime","armGroupLabels":["Atomoxetine 75mg","Atomoxetine 75mg plus placebo"]},{"type":"DRUG","name":"Placebo","description":"Oral administration at bedtime","armGroupLabels":["Placebo tablet","Placebo tablet plus placebo capsule"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo","description":"Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.","timeFrame":"Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)"}],"secondaryOutcomes":[{"measure":"Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo","description":"Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.","timeFrame":"Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)"},{"measure":"Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo","description":"Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.","timeFrame":"Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.\n* Mean AHI 10 to 45 events/h, inclusive\n* PGI-S: \\>1\n* BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive.\n\nExclusion Criteria:\n\n* Current clinically significant sleep disorder other than OSA\n* Clinically significant craniofacial malformation.\n* Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).\n* Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Santa Monica Clinical Trials","city":"Los Angeles","state":"California","zip":"90025","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Pacific Research Network","city":"San Diego","state":"California","zip":"92103","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"SDS Clinical Trials, Inc.","city":"Santa Ana","state":"California","zip":"92705","country":"United States","geoPoint":{"lat":33.74557,"lon":-117.86783}},{"facility":"Delta Waves","city":"Colorado Springs","state":"Colorado","zip":"80918","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Teradan Clinical Trials","city":"Brandon","state":"Florida","zip":"33511","country":"United States","geoPoint":{"lat":27.9378,"lon":-82.28592}},{"facility":"Research Centers of America -- Hollywood","city":"Hollywood","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"Sleep Medicine Specialists of South Florida","city":"Miami","state":"Florida","zip":"33176","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"NeuroTrials Research, Inc.","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Chicago Research Center","city":"Chicago","state":"Illinois","zip":"60634","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"The Center for Sleep & Wake Disorders","city":"Chevy Chase","state":"Maryland","zip":"20815","country":"United States","geoPoint":{"lat":39.00287,"lon":-77.07115}},{"facility":"Sleep Disorders Centers of the Mid-Atlantic (SDCMA)","city":"Glen Burnie","state":"Maryland","zip":"21061","country":"United States","geoPoint":{"lat":39.16261,"lon":-76.62469}},{"facility":"Neurocare","city":"Newton","state":"Massachusetts","zip":"02459","country":"United States","geoPoint":{"lat":42.33704,"lon":-71.20922}},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","zip":"48377","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}},{"facility":"Sleep and Attention Disorders Institute","city":"Sterling Heights","state":"Michigan","zip":"48314","country":"United States","geoPoint":{"lat":42.58031,"lon":-83.0302}},{"facility":"Minnesota Lung Center / Minnesota Sleep Institute","city":"Woodbury","state":"Minnesota","zip":"55125","country":"United 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States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Brian Abaluck, LLC","city":"Malvern","state":"Pennsylvania","zip":"19355","country":"United States","geoPoint":{"lat":40.03622,"lon":-75.51381}},{"facility":"Bogan Sleep Consultants LLC","city":"Columbia","state":"South Carolina","zip":"29201","country":"United States","geoPoint":{"lat":34.00071,"lon":-81.03481}},{"facility":"Velocity Clinical Research","city":"Greenville","state":"South Carolina","zip":"29615","country":"United States","geoPoint":{"lat":34.85262,"lon":-82.39401}},{"facility":"FutureSearch Trials of Neurology","city":"Austin","state":"Texas","zip":"78731","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}}]},"referencesModule":{"references":[{"pmid":"37812772","type":"DERIVED","citation":"Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"AD109 75/5mg","description":"AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg tablet following a 1-week titration with Atomoxetine 37.5 mg/Aroxybutynin 2.5 mg tablet."},{"id":"FG001","title":"AD109 75/2.5mg","description":"AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet following a 1-week titration with Atomoxetine 37.5 mg/Aroxybutynin 2.5 mg tablet."},{"id":"FG002","title":"AD504 75/100mg","description":"AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet /Trazodone 100 mg capsule following a 1-week titration with Atomoxetine 37.5 mg tablet /Trazodone 50 mg capsule"},{"id":"FG003","title":"AD504 75/50mg","description":"AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet / Trazodone 50 mg capsule following a 1-week titration with Atomoxetine 37.5 mg tablet /Trazodone 50 mg capsule"},{"id":"FG004","title":"Atomoxetine 75mg","description":"Atomoxetine Hydrochloride: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet alone or Atomoxetine 75 mg tablet plus placebo capsule, following a 1-week titration with Atomoxetine 37.5 mg tablet alone or Atomoxetine 37.5 mg tablet plus placebo capsule. Regimens were pooled for analysis."},{"id":"FG005","title":"Placebo","description":"Placebo: Oral administration at bedtime. Dose: Matching placebo tablet alone or matching placebo tablet plus matching placebo capsule. Regimens were pooled for analysis."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"43"},{"groupId":"FG003","numSubjects":"40"},{"groupId":"FG004","numSubjects":"64"},{"groupId":"FG005","numSubjects":"64"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"38"},{"groupId":"FG003","numSubjects":"38"},{"groupId":"FG004","numSubjects":"49"},{"groupId":"FG005","numSubjects":"59"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"15"},{"groupId":"FG005","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"12"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"}]},{"type":"Non-Compliance with Study Drug","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Other/Unknown","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety Set population: all randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"AD109 75/5mg","description":"AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg"},{"id":"BG001","title":"AD109 75/2.5mg","description":"AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg"},{"id":"BG002","title":"AD504 75/100mg","description":"AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Trazodone 100 mg"},{"id":"BG003","title":"AD504 75/50mg","description":"AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Trazodone 50 mg"},{"id":"BG004","title":"Atomoxetine 75mg","description":"Atomoxetine Hydrochloride: Oral administration at bedtime. Dose: Atomoxetine 75 mg"},{"id":"BG005","title":"Placebo","description":"Placebo: Oral administration at bedtime"},{"id":"BG006","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"63"},{"groupId":"BG005","value":"63"},{"groupId":"BG006","value":"292"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"37"},{"groupId":"BG004","value":"56"},{"groupId":"BG005","value":"58"},{"groupId":"BG006","value":"262"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"30"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.2","spread":"9.24"},{"groupId":"BG001","value":"51.5","spread":"9.22"},{"groupId":"BG002","value":"57.8","spread":"8.20"},{"groupId":"BG003","value":"53.9","spread":"8.81"},{"groupId":"BG004","value":"52.8","spread":"10.95"},{"groupId":"BG005","value":"54.9","spread":"9.03"},{"groupId":"BG006","value":"54.2","spread":"9.49"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"22"},{"groupId":"BG005","value":"27"},{"groupId":"BG006","value":"121"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"26"},{"groupId":"BG004","value":"41"},{"groupId":"BG005","value":"36"},{"groupId":"BG006","value":"171"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska 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American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"9"},{"groupId":"BG006","value":"41"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"31"},{"groupId":"BG004","value":"52"},{"groupId":"BG005","value":"48"},{"groupId":"BG006","value":"226"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"4"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"5"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"12"},{"groupId":"BG005","value":"11"},{"groupId":"BG006","value":"53"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"32"},{"groupId":"BG004","value":"51"},{"groupId":"BG005","value":"52"},{"groupId":"BG006","value":"239"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"63"},{"groupId":"BG005","value":"63"},{"groupId":"BG006","value":"292"}]}]}]},{"title":"Body Mass Index 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Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.","populationDescription":"mITT set: all randomized participants who received ≥1 dose and had ≥1 primary endpoint measurement. The two AD109 dose arms were combined as the primary analysis group per the pre-specified SAP (v1.0, April 2022), as the study was designed and powered to evaluate the overall effect of AD109 versus placebo rather than to compare individual dose levels. 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