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Article History

Received: 29 October 2024

Revised: 8 May 2025

Accepted: 21 May 2025

First Online: 19 June 2025

Competing interests

: MJHK, BWJHP, BC declare no conflict of interest. GMK served as a speaker for Angelini, Abbvie, Cybin, and H Lundbeck, as an advisor for Sanos, Onsero, Pangea Botanica, Gilgamesh, and Pure Technologies and as a research site for Reunion and Delix Therapeutics. BC: The views in this article do not necessarily represent the views of the National Institutes of Health, the Department of Health and Human Services, or the United States Government. PF is on the advisory board of Gedeon Richter, JNJ and Boehringer-Ingelheim, and gave paid talks for Gedeon Richter, Ostuka, JNJ, Boehringer-Ingelheim and Lundbeck. GSS is a full-time employee of Signant Health and has consulting agreements with Rapport Therapeutics, Intracellular, Merck, Kintsugi, and Cognitiv. KJR has performed consultation for Bionomics, Acer and Jazz Pharma; Scientific Advisory Boards for Sage, Boehringer Ingelheim, Senseye, Brain & Behavior Research Foundation and Brain Research Foundation, and received sponsored research support from Alto Neuroscience. FBD was an employee of EMA during the conceptual design, drafting and review of the manuscript. The views expressed in this article are the personal views of the author and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency with which the author is/was affiliated. HM is a full-time employee of Boehringer Ingelheim GmbH. JL is a full-time employee of H Lundbeck A/S. VM has no conflict of interest to declare. VM views and opinions presented in this manuscript are her own and should not be construed to represent an official FDA position or policy.