Primary endpoint
The primary endpoint was endogenous insulin production at 12 months, as assessed by the 2-h serum C-peptide rea under the curve (AUC) during a mixed meal tolerance test (MMTT). Endogenous insulin production was measured at baseline, and then at 3, 6 and 12 months. The primary endpoint was analyzed using a linear mixed model for repeated measures. At 12 months, the serum C-peptide AUC was higher in the pleconaril and ribavirin treatment group compared to the placebo group (average marginal effect (AME) = 0.057 at 12 months in the linear mixed model; 95% confidence interval (CI) = 0.004–0.11, 