Funding for this research was provided by:
National Health and Medical Research Council (APP1152232)
Received: 12 October 2019
Accepted: 19 June 2020
First Online: 6 July 2020
Ethics approval and consent to participate
: Central ethical approval has been confirmed from the Mater Misericordiae Ltd. Human Research Ethics Committee (on 14 February 2019, reference number HREC/MML/49348 (V1)), and we will not begin recruiting at other centres in the trial until local ethical approval has been obtained.This study will be conducted in compliance with all stipulations of this protocol, the condition of the ethics committee approval, the NHMRC National Statement of Ethical Conduct in Human Research (2007), the note of Guidance of Good Clinical Practice (CPMP/ICH-135/95), the Australian code for the Responsible Conduct of Research (2007) and all other relevant guidance documents and legislation. The investigators/researchers will also comply with their respective professional Codes of Conduct whilst conducting this research, as well as their relevant institutional policies and procedures.The study will be overseen by a data safety monitoring committee consisting of an independent statistician, clinicians, experts in pharmacy and drug addiction and consumer representatives.Regular update reports will be provided to the primary funding body, the Medical Research Future Fund, and to local ethics committees at each site. Results will be submitted to a peer review journal.All participants will give written informed consent to participate in the trial.
: Not applicable
: No competing interests to declare.