Statistical analyses

The primary analysis was conducted after all enrolled patients had completed the post-treatment week 12 visit or prematurely discontinued from the study. Efficacy, safety, and demographic analyses were performed on the ITT population. For Substudy 1, the primary efficacy endpoint was conducted on the ITT–PS population. The difference in SVR12 rate between the two arms (Arm A minus Arm B) of Substudy 1 was computed as well as the two-sided 95% confidence interval using the normal approximation to the binomial distribution. Non-inferiority of Arm A versus Arm B was considered established if the lower bound of this confidence interval was above −10%. Efficacy was also assessed in the modified ITT (mITT) population, which excluded patients who did not achieve SVR12 due to reasons other than virologic failure. Safety analyses compared the rate of adverse events and laboratory abnormalities between treatment groups (Arm A vs. Arm B) with the use of Fisher’s exact test.