Part I: - Proportion of subjects with Grade ≥ 3 treatment-related AEs within 28-day FU period - Proportion of subjects with AEs (all and serious) of any grade and independent of causality within 28-day FU period - Proportion of subjects with infusion related reactions within 24 hours of treatment - Proportion of subjects with hypersensitivity reactions within 28-day FU period Part II: - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period

Part I: - Proportion of subjects with Grade ≥ 3 treatment-related AEs within 28-day FU period - Proportion of subjects with AEs (all and serious) of any grade and independent of causality within 28-day FU period - Proportion of subjects with infusion related reactions within 24 hours of treatment - Proportion of subjects with hypersensitivity reactions within 28-day FU period Part II: - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period