Declaration of interests
MSHR (NT, Australia) is the trial sponsor. Study investigators working at MSHR and partnering institutes are solely responsible for the design, conduct and reporting of this RCT. The investigators and protocol authors declare no conflicts of interest. The trial is funded by the NHMRC. The study medicine and placebo are manufactured and supplied free of charge by Ddrops, Ontario, Canada. Neither Ddrops or the NHMRC had/will have any role in the trial study design, conduct, analysis or reporting.