Fig. 1

Phase 3 study design. After screening, participants entered an open-label run-in phase of up to 2Â weeks of treatment with buprenorphine/naloxone sublingual film (induction and stabilization), to achieve daily doses ranging from 8Â mg/2Â mg to 24Â mg/6Â mg. After run-in, Eligible participants were then randomly assigned (4:4:1:1) to receive BUP-XR 300Â mg/300Â mg, BUP-XR 300Â mg/100Â mg, or volume-matched placebo