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Article History

Received: 27 June 2024

Accepted: 24 October 2024

First Online: 7 November 2024

Declarations

:

: OPEN received a favourable Research Ethics Committee (REC) opinion from the Research Ethics Committees Northern Ireland (ORECNI) on 10/03/2022; REC reference: 22/NI/0010; IRAS project ID: 295297. Before inclusion into the study, informed consent was obtained from each participant who was 16 years old or older. Children and adolescents who were younger than 16 years were asked to give their informed assent before inclusion into the study, and additional informed consent was obtained from their parents. We conducted this investigation following the Helsinki Declaration’s guiding principles. This study has been registered with the International Standard Randomised Controlled Trial Number (ISRCTN) register on the 27/04/2022 under the unique identification number ISRCTN80075010. Current Protocol version 1.3; 2 December 2022.

: Not applicable. This manuscript reports results from anonymized data only.

: HH is the Principal Investigator on “Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study,” a COMPASS Pathways-funded and -sponsored proof-of-concept study testing psilocybin in AN. AHY participated in paid lectures and advisory boards for the following companies: Allegan, AstraZeneca, Bionomics Ltd, Boehringer Ingelheim, COMPASS, Eli Lilly, Janssen, LivaNova, Lundbeck, Neurocentrx, Novartis, Sage, Servier, Sumitomo Dainippon Pharma, and Sunovion. AHY is the Principal Investigator in the Restore-Life VNS registry study funded by LivaNova; Principal Investigator on ESKETINTRD3004: ‘An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression’; Principal Investigator on ‘The Effects of Psilocybin on Cognitive Function in Healthy Participants’; Principal Investigator on ‘The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (p-TRD)’; UK Chief Investigator for Novartis MDD study MIJ821A12201. All other authors declare no competing interests.