Data generating mechanisms
EVENT
We consider all possible data arising from the D3 trial. In particular, we assume that 166 patients (the sample size before adjustment for expected attrition) are randomised to each of the two arms, and we estimate (i) the probability that precisely 0, 1, 2,…, 166 of them experience the outcome of interest in the control arm under the assumption that the true control event risk is between 1 and 15%; and (ii) the probability that precisely 0, 1, 2,…, 166 of the individuals in the experimental arm had viral rebound both under the null hypothesis implied by the non-inferiority frontier and under the alternative hypothesis that the true risk is the same as in the control arm.