Study oversight

Participants provided written informed consent before study procedures. The study protocol was approved by St Vincent’s Hospital, Sydney Human Research Ethics Committee (Australia), Northern B Health and Disabilities Ethics Committee (New Zealand), London-Riverside Research Ethics Committee (England), and local ethics and governance committees at all sites. The study was conducted according to the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice (ICH/GCP). The study was registered with clinicaltrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT02634008","term_id":"NCT02634008"}}NCT02634008).