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Article History

Received: 21 September 2023

Accepted: 28 November 2023

First Online: 8 December 2023

Declarations

:

: The Ramsay Health Care HREC A has granted ethical approval to the study. Study psychiatrists will discuss informed consent in detail with potential participants, including a discussion of any questions/concerns regarding the study. Participants will commence study participation once written informed consent is obtained. Both prior to signing the consent form, and on the form itself, it will be made clear to potential participants that entry into the study is voluntary and if they opt not to participate this will in no way affect their relationship with the hospital or study investigators/clinicians. Participants provide consent for their de-identified data to be used in future research.

: To ensure confidentiality, all data collected will be de-identified. Research data will only be accessible to staff involved in the study as needed. Participants’ study information will not be released outside of the study without the written permission of the participant, except as required by the HREC, sponsor, or regulatory authorities. Where participant consent is provided for data to be re-used and shared with other researchers for future research projects, data will only be provided in a de-identified format and with separate ethics approval.

: Reasonable precautions against harms and steps to mitigate risks will be taken. In the trial protocol, safety will be closely monitored through ongoing care by the patients’ treating psychiatrist who will continue to oversee clinical progress and the welfare of his/her patient. Either the participant or his/her treating/admitting psychiatrist can withdraw the participant from the study at any time if there are concerns about clinical progress or welfare. Post-trial care will not be provided by study staff or investigators.

: Results of the research will be disseminated via publication of papers in academic journals, reports, and presentations at academic meetings and conferences. Only aggregated group (or subgroup) results will be analysed and reported as such. No identifiable information will be reported in any format, thus protecting the confidentiality of participants and other information collected during the study.

: N/A.

: DM declares his Visiting Medical Officer (VMO) status at Northside Clinic, SM declares his VMO status at Northside Clinic and role as the Medical Director of the Eating Disorder Unit at Northside Clinic, CL declares her VMO status at Northside Clinic and role as the Director of the Neurostimulation Unit at Northside Clinic, and MB declares his VMO status at Northside Clinic. The others have no conflicts of interest to declare.