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Article History

Received: 17 February 2026

Accepted: 24 August 2026

First Online: 12 September 2026

Declarations

Conflict of Interest: GWM, AS, PA, NM, and MRB are or were employees of Incannex Healthcare Pty Ltd and have shares in the company. ER and PR have no competing interests to declare that are relevant to the content of this article.

Ethical Approval: This study was carried out according to the principles of the Declaration of Helsinki, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R2) (2016) (as adopted in Australia), and the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007, incorporating all updates). The study protocol was approved (approval no. 2022-12-1434 dated 3 July 2023) by Bellberry Human Research and ethics committee (123 Glen Osmond Road, Eastwood, 5063, South Australia).

Consent to Participate: Written informed consent was obtained from each subject before any trial-related procedures were performed .

Consent for Publication: Not applicable.

Code Availability: Not applicable .

Data Availability Statement: All data generated or analyzed during this study are included in this published article. The datasets generated during and/or analyzed during the current study are related to a proprietary commercial formulation and as such will not be made available.

Authors Contributions: GWM, AS, PA, NM, and MRB contributed to the study design, data collection, analysis, interpretation, and manuscript preparation. ER and PR were study principal investigators who oversaw the study implementation, data collection, analysis, interpretation, and manuscript preparation. All authors read and approved the final version and submission of this manuscript.