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Sonia Ancoli-Israel served as a consultant\/advisory board member for Biogen, Eisai, Idorsia, Merck, NeuroVigil, Inc., Puretech, and Wesper. Thien Thanh Dang-Vu served as consultant and received speaker honoraria from Eisai, Paladin Labs, Idorsia, and Jazz Pharmaceuticals; and received research grants from Paladin Labs and Jazz Pharmaceuticals. Kazuo Mishima received speaker honoraria from Eisai Co., Ltd., MSD Inc., and Takeda Pharmaceutical Co., Ltd.; and received research grants from Eisai Co., Ltd. and Takeda Pharmaceutical Co., Ltd. Margaret Moline is an employee of Eisai Inc. Kate Pinner is an employee of Eisai Ltd. Manoj Malhotra is a former employee of Eisai Inc. and is affiliated with Harlem Hospital, New York (NY, USA).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The protocol, protocol amendments or revisions, and informed consent form for Study 303 were approved by a qualified institutional review board and\/or independent ethics committee. The study was conducted in accordance with the ethical standards in the 1964 Declaration of Helsinki and its later amendments or comparable standards. The study is registered on ClinicalTrials.gov (NCT02952820) and on EudraCT (2015\u2013001463-39). Additional study details, including site information, can be found at .","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}