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Article History

Received: 17 November 2017

Accepted: 1 June 2018

First Online: 27 June 2018

Ethics approval and consent to participate

: This research received approval from each site and was fully compliant with the code of ethics of the World Medical Association (Declaration of Helsinki), as well as the standards established by the authors’ institutional review board and the granting agency. Written informed consent has been sought from all participants prior to participation. The Human Research Ethics Committee granted approval on 26 February 2015 (number 2015/016), as did the multi-site insurance companies, and the trial was registered on 9 April 2015 (registration number ANZCTR – ACTRN12615000326594).

: Written informed consent has been obtained from the participants for publication of the manuscript’s grouped data and figures (data relating to any single individual will not be published). The completed consent forms are securely held by the authors’ institution and are available for review by the editor-in-chief.

: The authors declare that they have no competing interests.

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