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Article History

Received: 8 May 2025

Accepted: 13 August 2025

First Online: 11 September 2025

Declarations

:

: Jeff Schein is an employee of Otsuka Pharmaceutical Development & Commercialization. Martin Cloutier, Marjolaine Gauthier-Loiselle, Maryaline Catillon, Anaïs Lemyre, Alice Qu, and Frederic Kinkead are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Otsuka Pharmaceutical Development & Commercialization, Inc, which funded the development and conduct of this study and manuscript. Ann Childress received research support from Aardvark, Allergan, Axsome, Emalex, Akili, Cingulate, Corium, Ironshore, Les Laboratoires Servier, Lumos, Neurocentria, Otsuka, Purdue, Adlon, Sunovion, Tris, KemPharm, and Supernus; was on the advisory board of Corium, Otsuka, Tris, and Supernus; received consulting fees from Aardvark, Alora, Axsome, Aytu, Cingulate, Corium, Lumos, Medison Pharma, Neurocentria, Noven, Otsuka, Sky, Tris, KemPharm, Supernus, and Tulex; received speaker fees from Takeda, Corium, Ironshore, Tris, and Supernus; and received writing support from Otsuka, Takeda, Corium, Ironshore, Purdue, and Tris.

: The study was considered exempt research under 45 CFR § 46.104(d)(4) as it involved only the secondary use of data that were de-identified in compliance with the Health Insurance Portability and Accountability Act (HIPAA), specifically, 45 CFR § 164.514.