Funding for this research was provided by:
Alkermes Inc. (N/A)
Received: 17 June 2020
Accepted: 17 February 2021
First Online: 24 March 2021
Ethics approval and consent to participate
: Both the 52-week safety study (ExternalRef removed identifier: NCT01626456) and the long-term extension (ExternalRef removed identifier: NCT01895452) were 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 with local regulations and International Council for Harmonisation guidelines. Study protocols and amendments were approved by the independent ethics committee/institutional review board for each study site. All patients provided written informed consent before participating in both studies.
: Not applicable.
: At the time of the study, Drs. Sun, Weiden, and O’Sullivan were employees of Alkermes, Inc., and may own stock in the company. Drs. McEvoy and Lysaker have received consulting fees from Alkermes, Inc., in the past.