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Article History

Received: 18 May 2023

Accepted: 26 May 2023

First Online: 16 June 2023

Declarations

:

: The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving human subjects/patients were approved by the National Bioethics Committee of Pakistan (Ref: No.4-87/NBC-905/23/1199) and the Centre for Addiction and Mental Health (CAMH) Research Ethics Board, Toronto, Canada (REB # 2023/017). All members of the research team will comply with the International Conference on Harmonization Good Clinical Practice (ICH-GCP) Guideline. Research staff will be trained in good clinical practice (GCP) and will not begin data collection until the GCP certification is successfully completed. All participants will provide written informed consent before their participation in the trial. Consent will be obtained from family members and carers at the same time as patient participants. Participation in the trial will be voluntary and participants will have the right to withdraw from the study at any time, for any reason. Withdrawal from the trial will have no effect on routine care. All information provided by the participants will be kept confidential and authorization will be required prior to accessing data. Patient-identifying information will not be published. Privacy and confidentiality of participants will be maintained.

: Not applicable.

: MIH has been a scientific advisor to MindSet Pharma, Wake Network and Psyched Therapeutics. He has acted as site principal investigator for a trial sponsored by COMPASS Pathways Ltd. MIH is a member of the BJPsych Open editorial board and did not take part in the review or decision-making process of this paper. IC reported receiving support to attend and present scientific papers for national and international educational meetings and conferences from various pharmaceutical companies outside the submitted work. NH reported receiving grants from the National Institute of Health Research, Wellcome Trust, Medical Research Council, and Grand Challenges Canada outside the submitted work and serving as the president of the Manchester Medical Society and as a National Institute for Health and Care Research (NIHR) senior investigator. No other disclosures were reported.