Methods 
All procedures involved in this trial were conducted in compliance with the National Statement on Ethical Human Research and the Australian Code for the Responsible Conduct of Research. Ethical approval was obtained from the Melbourne Health Ethics Committee, Melbourne Australia (HREC/61926/MH-2020). The study was designed according to the Consolidated Standard of Reporting Trials (CONSORT) guidelines and publications associated with the trial are reported according to the CONSORT 2010 Statement [