2.1. Ethics and Protocol Registration 
This trial was prospectively registered with Sydney Local Health District Clinical Trials (Protocol No X14-0366) and the Australian New Zealand Clinical Trials Registry (ACTRN12615001004550; Universal Trial Number: U1111-1170-4543) and was conducted according to the guidelines set out in the Declaration of Helsinki. Procedures were approved by the University of Sydney Human Research and Ethics Committee (Project 2015/074). All participants provided informed consent. 