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Article History

Received: 11 November 2021

Accepted: 4 May 2022

First Online: 27 May 2022

Declarations

:

: This project will be conducted according to the NHMRC national Statement on Ethical Conduct in Human Research (2007 and updates) and the World Medical Association of Helsinki (2013 and updates). Ethical approval was granted by the Peter MacCallum Human Research Ethics Committee in September 2021 (HREC/78080/PMCC). The trial is registered to the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN: ACTRN12622000420741). All participants will provide signed informed consent and may stop their involvement in the project at any time. All identifiable participant information will be stored in a password-protected database, and participants will be given a unique study identifying code to protect confidentiality before, during and after participation in the trial. Participants will receive a group summary of results at the completion of the project. Adverse events are unexpected and will be reported to the clinical trials sponsorship committee.

: Not applicable for protocol paper.

: The authors declare no competing interests.