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Article History

Received: 7 November 2022

Accepted: 24 July 2023

First Online: 31 July 2023

Declarations

:

: The Institutional Review Boards of the study sites (San Diego State University, University of Miami, Albert Einstein College of Medicine, and University of Illinois at Chicago) and the Coordinating Center (University of North Carolina-Chapel Hill) each approved the study protocol. The study was conducted in accordance to the Declaration of Helsinki and all participants provided informed consent. This study was approved by the ethics committee of the National Center of Neurology and Psychiatry (A2020-012).

: Not applicable.

: Dr. Saitoh reports personal fees from Yoshitomi Pharmaceutical and Eisai, outside the submitted work. Dr. Yoshiike reports personal fees from MSD and Takeda Pharmaceutical, outside the submitted work. Dr. Kaneko reports personal fees from Eisai, Meiji Seika Pharma, Otsuka Pharmaceutical, and Sumitomo Pharma, outside the submitted work. Dr. Utsumi reports speaker’s honorarium from Eisai, outside the submitted work. Dr. Matsui reports speaker’s bureau from Eisai, Meiji Seika Pharma, MSD, Otsuka Pharmaceutical, Yoshitomi Pharmaceutical, and Takeda Pharmaceutical, outside the submitted work. Dr. Nagao reports personal fees from Dainippon Sumitomo, Takeda Pharmaceutical, outside the submitted work. Dr. Kawamura reports speaker’s honorarium from Otsuka Pharmaceutical, outside the submitted work. Dr. Aritake-Okada reports personal fees from Idorsia Pharmaceutical Ltd and Philips, grants and personal fees from Takeda Pharmaceutical Co., and grants from Kao Corporation, outside the submitted work. Dr. Kadotani is associated with a laboratory that was supported by donations from Fukuda Lifetech Co., Ltd. And Fukuda Life Tech Keiji Co., Ltd., Tanaka Sleep Clinic, Akita Sleep Clinic, and Ai Care Co., Ltd. To Shiga University of Medical Science, outside the submitted work. Dr. Kadotani received grants from Merck Sharp and Dohme LLC/MSD K.K. (the Investigator-Initiated Studies Program), Eisai Co., Ltd., and SECOM Science and Technology Foundation, consulting fees from Takeda Pharmaceutical Co., Ltd., Aculys Pharma, Inc., and Seed Planning, Inc., speaker’s honorarium from Fukuda Life Tech Keiji Co., Ltd., Eisai Co., Ltd., Nobelpharma Co., Ltd., Ono Pharmaceutical CO., Ltd., and Takeda Pharmaceutical Co., Ltd., and honoraria for manuscript writing from Nipponrinshosha Co., Ltd., Iyaku-Joho-Kenkyujo,Inc. and the Yomiuri Shimbun, outside the submitted work. Dr. Kuriyama reports research grants from Otsuka Pharmaceutical, Mitsubishi Tanabe Pharma, and Pfizer, research grants and speaker’s honorarium from Meiji Seika Pharma, Eisai, MSD, Takeda Pharmaceutical, Tsumura, and Eli Lilly, and speaker’s honorarium from Yoshitomi Pharmaceutical and Sumitomo Pharma, outside the submitted work. Dr. Suzuki has received research grants from Mochida Pharmaceutical and Shionogi Pharma, research grants and speaker’s honorarium from EA Pharma, Eisai, Otsuka Pharmaceutical, Sumitomo Pharma and Takeda Pharmaceutical, and speaker’s honorarium from Meiji Seika Pharma, MSD, Viatris, and Yoshitomi Pharmaceutical, and payment for expert testimony from Mochida Pharmaceutical, outside the submitted work. All other authors report no financial relationships with any other commercial interests.