Ethics Approval
RECRUITMENT
Approval was sought from the Allendale Institutional Review Board (PGI-BIG4-1331-MS). This study was registered at ClinicalTrials.gov (NCT02195531). Data collection took place at 6 US sites: SleepMed, South Carolina; Sleep Med, Georgia; Pulmonary Associates, Arizona; Arkansas Center for Sleep Medicine, Arkansas; NeuroTrials Research, Georgia; and Center for Sleep Medicine, Pennsylvania. Recruitment and randomization were conducted from 2014 until 2015. All the participants provided written informed consent.