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Article History

Received: 5 September 2024

Accepted: 20 March 2025

First Online: 2 April 2025

Declarations

:

: The study protocol version 6.0 28 May 2020 was approved by the Human Research Ethics Committees of the South Western Sydney Local Health District on 15 June 2020 (reference number 2020/ETH00754 ) and St John of God Health Care on 18 August 2020 (reference number 1704). Each update to the protocol has been approved by the relevant ethics committee.The study will be performed according to the National Statement on Ethical Conduct in Human Research [, ]. As per the National Statement (2018 and 2023, section 3.1.5), placebo controlled trials are ethically acceptable where the current standard of care includes the absence of the intervention being tested and there is no risk of significant harm in the absence of the intervention. All investigators will undergo training in Good Clinical Practice for clinical trials and will complete a study start up site or remote visit that involves training of the site principal investigator and all delegated personnel, on the approved versions of the trial protocol, standard operating procedures and/or relevant essential documents. The protocol and a statistical analysis plan will be published in an open-access journal. The protocol complies with SPIRIT guidelines [] and the study will be reported according to the CONSORT guidelines [].

: A model consent form and participant information sheet have been provided as Supplementary Material.

: The authors declare that they have no competing interests.