Statistical principles
BLIND
The analysis will be conducted by biostatisticians from the Methods and Implementation Support for Clinical and Health (MISCH) Research Hub (University of Melbourne, Australia). After all study data are available and have been cleaned, a blinded review meeting will be held prior to database lock. The final statistical analysis plan will be signed off before breaking the blind. The analysis of the primary outcome will be independently checked by a senior biostatistician at MISCH and any discrepancies between the two analyses will be discussed and resolved by consensus. All statistical tests will be performed in Stata/SE version 16.1 (Stata Corporation, College Station, TX, USA), and confidence intervals (CIs) reported, at the two-sided 5% level of significance unless stated otherwise.