Statistical analysis
All patients who received ≥ 1 infusion and had a visit in the extension period were included in the safety analyses. All patients who had a valid baseline assessment and a valid assessment of MMDs in the extension period were included in the efficacy analyses. Baseline was the 28-day screening period that occurred before the placebo-controlled treatment period.A mixed model for repeated measures similar to the one used for the primary endpoint (2-sided; 95% CI) [