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Article History

Received: 9 November 2024

Accepted: 19 May 2025

First Online: 29 May 2025

Declarations

:

: KAC has consulted for MedAvante-ProPhase, and A. Stein- Regulatory Affairs Consulting, Ltd. in the past, and currently serves as a consultant to Cronos Clinical Consulting Services, Inc. and Relmada Therapeutics, Inc. In the last 10 years, DVI has received consulting honoraria from Alkermes, Allergan, Angelini, Autobahn, Axsome, Biogen, Boehringer Ingelheim, Centers for Psychiatric Excellence, Clexio, Delix, Jazz, Lundbeck, Neumora, Otsuka, Precision Neuroscience, Relmada, Sage, and Sunovion and has received research support (through his academic institutions) from Alkermes, AstraZeneca, Brainsway, Litecure, Neosync, Otsuka, Roche, and Shire. PC consulted for Janssen Research and Development and for Niraxx Inc; was funded by PhotoThera Inc., LiteCure LLC and Cerebral Sciences Inc to conduct studies on transcranial photobiomodulation; is a shareholder of Niraxx Inc; and has filed several patents related to the use of near-infrared light in psychiatry. The other authors have nothing to disclose.

: The study protocol was reviewed and approved by the New York University School of Medicine Institutional Review Board (IRB #i20-00217).

: All participants gave written informed consent before any study related procedures were performed, in accordance with the Declaration of Helsinki.

: ClinicalTrials.gov Identifier: NCT04366258.

: 30 March 2020.