Document is current

Article History

Received: 5 February 2024

Accepted: 21 November 2024

First Online: 27 November 2024

Declarations

:

: The study protocol and other related documents were approved by Canadian Shield Ethics Review Board (Burlington, ON) on 29 Oct 2019. This study was conducted in accordance with the protocol and with the consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable ICH Good Clinical Practice guidelines, and applicable local and federal laws and regulations.

: The investigator or the investigator’s representative explained the nature of the study to the participant or the participant’s legally authorized representative and answered any questions. Participants were informed that their participation was voluntary and that study reports or publications reporting on the study would not disclose the participant’s identity without specific consent. Participants wishing to participate in the study, or their legally authorized representative, signed a statement of informed consent that met the requirements of local regulations, ICH guidelines, and the research ethics board. The authorized person obtaining informed consent also signed the informed consent form and a copy was provided to the participant or the participant’s legally authorized representative. Written informed consent was obtained prior to all study-related procedures.

: Not applicable.

: JRB is employed by and MJA provides consulting services for MSP Starch Products Inc., Carberry, MB, Canada. MSP Starch Products Inc. sister company McPharma Biotech holds relevant patents US11058711B2, CA3024201A1, AU2017294806A1, and provisional patent PCT/CA2021/051443 based on the work presented herein.