Ethics approval and consent to participate {24}
The protocol for this clinical trial has been reviewed and approved on 19 June 2015 by the Northern Sydney Local Health District Human Research Ethics Committee (HREC). This HREC is constituted and operates in accordance with the National Health and Medical Research Council’s ‘National Statement on Ethical Conduct in Human Research’ and the CPMP/ICH Note for Guidance on Good Clinical Practice. All patients must provide written informed consent before being enrolled in the trial.