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Article History

Received: 16 March 2017

Accepted: 1 December 2017

First Online: 28 December 2017

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 (21/12/2011), 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, (16/02/2016), New South Wales, Victoria & Queensland, Western Sydney Local Health District Ref HREC/13/WMEAD/165 (30/04/2013), South Adelaide Clinical HREC Ref 275.14 -HREC/14/SAC/284 (01/09/2014), The Alfred HREC for Caulfield Hospital Victoria Ref 248/16 (19/08/2016). Calvary Health Care Bruce HREC Ref 29-2014 (07/04/2015). New Zealand, Central Health and Disability Ethics Committee Ref 14/CEN/39 (17/04/2014)). EFFECTS: Stockholm Ethics Committee Ref 2013/1265-31/2 (30/09/2013). No centre can start recruitment until it has received relevant ethics and regulatory approvals. Informed consent is obtained before the patient is enrolled except where it has been waived. Consent procedures had to comply with national requirements, so that in FOCUS and AFFINITY approval was obtained for consent by either patient or proxy, AFFINITY also has approval for waiver of consent, while in EFFECTS patients have to be capable of consenting for themselves.

: Not applicable.

: None of the authors declare 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 below). None of the authors have any non-financial competing interests.

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