Cheng, Jocelyn Y.
Moline, Margaret
Zammit, Gary K.
Filippov, Gleb
Bsharat, Mohammad
Hall, Nancy
Article History
Accepted: 18 February 2021
First Online: 16 March 2021
Declarations
:
: This study was financially supported by Eisai Inc., Woodcliff Lake, NJ, USA. Eisai Inc. is the owner and manufacturer of lemborexant. The sponsor is responsible for the design of the study; collection, analysis, and interpretation of the data; writing the report; and the decision to submit the paper for publication. The investigators retained full independence in the conduct of this research.
: JYC, MM, GF, and NH are employees of Eisai Inc. MB is a former employee of Eisai Inc. GKZ is an employee and shareholder of Clinilabs Drug Development Corporation; has ownership interest in the Sleep Disorders Institute and Home Sleep and Respiratory Care; has served as a consultant for Eisai Inc., Janssen Pharmaceutica, Purdue, and Takeda; and has served on the speaker’s bureau for Merck.
: All procedures performed in the study involving human subjects were in accordance with the ethical standards of the institutional review boards at Advarra, BioMed, and Chesapeake (Pro00024281), and followed principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the 1964 Helsinki Declaration and its later amendments. This statement reflects the institutions where the study was conducted, and therefore approval was not sought by the author’s institutions/affiliations. Informed consent was obtained in writing from all subjects before any screening procedures.
: Not required.
: De-identified subject data that underlie the results reported in this article will not be made available, but summary information will be made available.
: Not required.
: All authors made a significant contribution to the work reported, whether in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.