Funding for this research was provided by:
National Health and Medical Research Council (1088902)
Text and Data Mining valid from 2018-05-18
Received: 31 August 2017
Accepted: 28 March 2018
First Online: 18 May 2018
Ethics approval and consent to participate
: Ethics Approval and consent to participate: South Eastern Sydney Local Health District Human Research Ethics Committee. Ref: 14/289 (HREC/14/POWH/701). Hunter New England Local Health District and Western Sydney Local Health District received site-specific ethical approval. All participants signed a Participant Information Consent Form [PICF] before being enrolled in the study. Informed consent involved a 3-step process. 1. Verbal information about the trial was given to potential participant either face-to-face or over the telephone during an initial screen. 2. Participants eligible for a medical screen were asked to sign a ‘consent to participate in a medical screen’ form before seeing the trial medical officer. 3. If participant was deemed eligible by trial medical officer, the medical officer/trial researcher verbally discussed the trial to the participant and invited any queries or concerns to be addressed. The participant was given a copy of the main PICF to take home and review. The PICF was signed by the participant and a witness on day 1 of commencing the trial.
: The participant information consent form includes a section relating to consent for de-identified data to be published. This is however not applicable for this paper.
: The authors declare that they have no competing interests.
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