Statistics and reproducibility
DISEASE
Statistical method was used to predetermine sample size. We hypothesized that cyclosporine plus corticosteroids would result in a mean change in ETDRS score that was no less than seven letters (MCID) lower than the mean change by adalimumab plus corticosteroids. Assuming the true difference of 0 between the two treatment groups in mean changes and a standard deviation of 10, we estimated that a sample size of 110 participants, accounting for a dropout rate of 20%, would provide 90% power to show the non-inferiority at a margin of −7 letters at a one-side significance level of 2.5%.This was a randomized study. No data were excluded from the primary analysis. The Investigators were aware of treatment allocation during trial, but they were blinded to primary outcome assessment.The primary effectiveness analyses were based on the intention-to-treat population comprised all randomized patients regardless of their adherence to assigned treatment as well as on the per-protocol population that included the subset of patients who completed a full treatment course without major protocol violations. Safety analyses were based on the safety population that included all those having received at least one dose of assigned treatment.The primary outcome as well as the other continuous outcomes was analyzed with the generalized estimating equation with identity link to calculate the least-squares mean of changes from baseline to week 26 in each treatment group and the difference in means between the two treatment groups, accounting for baseline value, disease phase and the correlation between eyes of the same individual (if the unit of analysis was by eye instead of by individual). We used the independence assumption about the correlation structure with the robust standard error estimator in the generalized estimating equation. We also tested other assumptions about the correlation structure in sensitivity analyses but found that the choice of working correlation matrix had little impact on results (Supplementary Table 