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Article History

Received: 1 November 2020

Accepted: 26 January 2021

First Online: 8 February 2021

Ethics approval and consent to participate

: This study was approved by the St. Vincent’s Hospital Human Research Ethics (reference number LRR 069/20) on 23 September 2020 and was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR number ACTRN12620001132932) on 30 October 2020. The principal investigator will provide an annual progress report to the HREC, and the HREC will be notified in writing immediately of any proposed changes to the trial. Only once approval has been received from the HREC will changes be made to the trial and the clinical trial registry notified. Verbal consent will be obtained by the research associate from all study participants prior to enrolment. It is anticipated adverse events related to this trial will be few; however, if any do occur, they will be reviewed by the study chief investigator and reported to the HREC. Patients are free to withdraw from the trial at any time without providing a reason. Patients will be informed that if they decide to withdraw from the project, personal and health information already collected will be retained. Patients will be informed that if they do not want this to occur they are to notify the researcher at the time of withdrawing. Patients will also be informed that trial results will be shared with the scientific community and may be published in a scientific journal, but any such publication would not contain identifiable data. Details outlining participants’ rights to access their data, study results, how study data will be used, and the processes in place to ensure individual confidentiality is protected, are all specified in the participant information and consent form (see Additional file InternalRef removed).

: Not applicable

: The authors declare no competing interests.