Received: 15 July 2020
Accepted: 4 November 2020
First Online: 25 November 2020
Ethics approval and consent to participate
: Each trial has received approval for its protocol and trial materials from the relevant local ethics committees and regulatory authorities in their respective countries (FOCUS: Scotland A Research Ethics Committee (for UK) Ref 11/SS/0100 (21 December 2011); AFFINITY: Western Australia, Royal Perth Hospital Human Research Ethics Committee Ref 2011-131 (24/02/2012); St John of God Healthcare HREC for St John of God Hospital Midland, Western Australia Ref 894 (16 February 2016); New South Wales, Victoria and Queensland, Western Sydney Local Health District Ref HREC/13/WMEAD/165 (30 April 2013); South Adelaide Clinical HREC Ref 275.14 -HREC/14/SAC/284 (01 September 2014); The Alfred HREC for Caulfield Hospital Victoria Ref 248/16 (19 August 2016); Calvary Health Care Bruce HREC Ref 29-2014 (07 April 2015); New Zealand, Central Health and Disability Ethics Committee Ref 14/CEN/39 (17 April 2014); EFFECTS: Stockholm Ethics Committee Ref 2013/1265-31/2 (30 September 2013)).
: Not applicable
: None of the authors declares any financial competing interests relating to this research other than the chief investigators of these three trials having received grant funding to support the trials (see Funding). None of the authors has any non-financial competing interests.