Ethics approval and consent
The study was performed in accordance with the Declaration of Helsinki, with central or institutional ethics and local research governance approval. The MoST program has been approved by the St Vincent’s Hospital Sydney Human Research Ethics Committee (reference, HREC/16/SVH/23), as has this clinical trial. All participants provided written informed consent to partake in this study. An independent data and safety monitoring committee provided independent assessments of patient safety and trial progress.