All potential participants completed a 2 week, single-blind, placebo run-in period with subsequent randomisation of eligible participants done centrally using an interactive web response system and a computer-generated randomisation schedule. Participants in CANVAS were randomly assigned in a 1:1:1 ratio to receive canagliflozin 300 mg, canagliflozin 100 mg or matching placebo, and participants in CANVAS-R were randomly assigned in a 1:1 ratio to receive canagliflozin or matching placebo (initially 100 mg with optional uptitration to 300 mg).
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