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Article History

Received: 13 July 2024

Accepted: 7 September 2024

First Online: 27 September 2024

Declarations

:

: The study will be conducted according to the principles of the Declaration of Helsinki and in accordance with the ICH-GCP guidelines and the local regulations. This study protocol and the master informed consent form have been approved by the Monash Health Human Research Ethics Committee. The study was first registered on 20.04.2022 in the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000580774. If a patient agrees to participate in the study, written informed consent will be obtained after which participants will complete baseline assessment and then be randomly allocated to the intervention group or control group. Any modifications to the protocol which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendments will be agreed upon by the project group and approved by Monash Health HREC prior to implementation and notified to the participating sites in accordance with local regulations.

: Not applicable.

: The authors declare no competing interests.