The primary efficacy variable used in the main analysis is the mean of the available ONLS values at month 12 and month 15.

The ONLS is a disability scale that was derived and improved from the Overall Disability Sum Score (ODSS) to measure limitations in the everyday activities of the upper limbs (rated on 5 points) and the lower limbs (rated on 7 points). The total score is a 12-point scale: 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition.

Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).