Received: 24 March 2022
Accepted: 27 June 2022
First Online: 8 July 2022
: The study was approved by the independent ethics committee or institutional review board for each of the 21 study sites: San Diego, California, United States, 92108; Santa Monica, California, United States, 90404; Colorado Springs, Colorado, United States, 80918; Bradenton, Florida, United States, 34201; DeLand, Florida, United States, 32720; Miami, Florida, United States, 33125; Tampa, Florida, United States, 33634; Winter Haven, Florida, United States, 33880; Prairie Village, Kansas, United States, 66206; Boston, Massachusetts, United States, 02131; North Attleboro, Massachusetts, United States, 02760 & 02481; Wellesley, Massachusetts, United States, 02481; Minneapolis, Minnesota, United States, 55402; Brooklyn, New York, United States, 11229; Rochester, New York, United States, 14609; Dayton, Ohio, United States, 45432; Mount Pleasant, South Carolina, United States, 29464; Chattanooga, Tennessee, United States, 37421; Fort Worth, Texas, United States, 76104; and Bellevue, Washington, United States, 98007. The PREVAIL study was conducted in accordance with standards of Good Clinical Practice as defined by the International Conference on Harmonisation and all applicable federal and local regulations. All study documentation was approved by the local review board at each site or by a central institutional review board or ethics committee. All patients provided written informed consent prior to their participation in the study.
: Not applicable.
: AB has served on advisory boards for AbbVie, Aeon, Alder, Amgen, Biohaven, Eaglet, Eli Lilly, Impel, Lundbeck, Novartis, Promius, Revance, Supernus, and Teva; and has received funding for speaking from AbbVie, Amgen, Avanir, Biohaven, Depomed, Eli Lilly, Impel, Lundbeck, Pernix, Promius, Supernus, and Teva. AE and BE are employees of H. Lundbeck A/S. JH is an employee of Pacific Northwest Statistical Consulting, Inc., a contracted service provider of biostatistical resources for H. Lundbeck A/S. RC was an employee of Lundbeck at the time of manuscript development.