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Article History

Received: 5 July 2025

Accepted: 28 November 2025

First Online: 16 December 2025

Declarations

:

: Administrative site approval was obtained for the study from the Department of Medical Research at SHC (CAN2302). Phases one to three obtained approval from the Faculty of Medicine and Health Sciences Institutional Review Board (IRB) at McGill University (IRB internal number A03-M11-23A) and was deemed to involve no more than minimal risk. Ethics review and approval were conducted in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2, 2nd Edition), the Cadre de référence ministériel pour la recherche avec des participants humains (MSSS, 2020), and the Food and Drugs Act (17 June 2001). The study also complies with the U.S. Code of Federal Regulations governing research on human subjects (Title 45 CFR 46; FWA 00004545) and adheres to internationally accepted principles of Good Clinical Practice and the Declaration of Helsinki. Informed consent was obtained from all participants. Ethics approval for phases 4 and 5 of the study will be obtained upon completion of phase 3, prior to the initiation of any further data collection.

: Not applicable.

: The authors declare no competing interests.