The study was approved by the Alfred Hospital Research Ethics Committee (project number 174/10) and the University of Melbourne Ethics Committee (project ID 1034462). Written informed consent was obtained from each participant.or the consent of minors (16- to 17-year-olds), an assessment of competency to participate in the study was undertaken by the research nurse. The HYPER study was also registered on The Australian New Zealand Clinical Trials Registry (ACTRN12611000857909).