Punia, Vineet http://orcid.org/0000-0002-0552-6736
Klein, Pavel http://orcid.org/0000-0001-7244-3722
Mihaylova, Temenuzhka http://orcid.org/0000-0002-9323-5823
Biton, Victor
Samad, Omar
Ngo, Leock Y. http://orcid.org/0000-0002-8184-1367
Kumar, Dinesh
Malhotra, Manoj
Funding for this research was provided by:
Eisai Incorporated
Article History
Received: 24 January 2024
Revised: 23 April 2024
Accepted: 24 April 2024
First Online: 10 May 2024
Declarations
:
: Vineet Punia has carried out consultancy and/or been on an advisory board for Catalyst Pharmaceuticals, Eisai Inc., and UNEEG Medical. Pavel Klein has served as a consultant for Abbott, Angelini, Arvelle Therapeutics, Neurelis, SK Life Science, and UniQure; as a consultant, advisory board member, and speaker to Aquestive, Eisai Inc., Sunovion, and UCB Pharma; is a member of the Medical Advisory Board of Stratus and of the Scientific Advisory Board of OB Pharma; is the CEO of PrevEp; has received speaker’s honoraria from Eisai Inc.; and has received research support from CURE/Department of Defense and National Institute of Health. Temenuzhka Mihaylova and Victor Biton have no real or apparent conflicts of interest to disclose. Omar Samad and Dinesh Kumar are employees of Eisai Inc. Leock Y Ngo and Manoj Malhotra are former employees of Eisai Inc.
: The study protocol was approved by Cleveland Clinic Institutional Review Board (study number: 18–045) and had therefore been performed in accordance with the ethical standards laid down in the Declaration of Helsinki.
: All participants provided written informed consent before participation in the study and after the study procedures had been fully explained. The informed consent form included a disclaimer that data will be anonymized and published.