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Article History

Received: 2 April 2018

Accepted: 13 May 2019

First Online: 10 June 2019

Ethics approval and consent to participate

: Ethics approval was granted on 2 February 2017 by the Western Sydney University Human Research Ethics committee (H11958). The trial was registered with the Australasian Clinical Trials Registry (ACTRN12617000945325) on 30 June 2017. Participants will provide oral informed consent and written informed consent at the time of screening (prior to being enrolled in the trial).

: Not applicable.

: As a medical research institute, NICM receives research grants and donations from foundations, universities, government agencies, individuals, and industry. Sponsors and donors provide untied funding for work to advance the vision and mission of the Institute. The project that is the subject of this article was not undertaken as part of a contractual relationship with any organisation other than the funding declared in the Acknowledgements. It should also be noted that NICM conducts clinical trials relevant to this topic area, for which further details can be provided on request. The sponsors will in no way have access to or influence the data from this project. The authors declare that they have no competing interests.