Pre-specified sensitivity analyses
We examined whether substantial amendment to protocol SA6 (expanding the inclusion criteria to including participants treated with metformin alone, as well as metformin and sulfonylureas) affected the main findings by adding in an “epoch” term to the model, where “epoch” was a binary variable representing before or after the change in inclusion criteria.We repeated the main analysis but including only participants who completed the full treatment period (at least 15 weeks to allow for flexibility in arranging study visits).We examined whether receiving the study drug for >18 weeks (substantial amendment to protocol SA12 in relation to COVID-19 pandemic) affected the main findings, by adding in a binary variable to the model for those with treatment periods greater or less than 18 weeks.