Received: 24 March 2021
Accepted: 5 August 2021
First Online: 8 October 2021
: The ALPINE study (ExternalRef removed identifier: ExternalRef removed [trial registration date: 15/11/2017]) was designed and carried out in accordance with the principles of Good Clinical Practice that have their origin in the Declaration of Helsinki and its amendments and in accordance with local regulations and International Council for Harmonisation guidelines. The study protocol and amendment (available at ExternalRef removed) were approved by the independent ethics committee/institutional review board for each study site. The institutional review board registered with the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration for the ALPINE study is Copernicus Group Independent Review Board (IRB00001313). All participants provided written informed consent before any study-specific procedures were conducted.
: Not applicable.
: HAN is a consultant or on advisory boards for Acadia, Alkermes, Inc., Allergan, Indivior, Intra-Cellular, Neurocrine, Sunovion, and Teva; and is on the speakers’ bureaus for Acadia, Alkermes, Inc., Allergan, Indivior, Intracellular, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Sunovion, and Teva.DPW reports receiving research support from Novartis, J&J PRD, Sunovion, Janssen, Alkermes, Inc., Allergan, Takeda, Otsuka, Noven, CoMentis, Intra-Cellular, Lupin, Avanir, Lundbeck, Roche, Boehringer Ingelheim, Acadia, and Sage; and has consulting arrangements with Otsuka and Janssen.YD, SY, and AC are employees of Alkermes, Inc., and may own stock/options in the company.PJW and BY were employees of Alkermes, Inc., at the time of the analysis and may own stock/options in the company.