Statistical analysis
DISEASE CHARACTERISTIC
Descriptive statistics were used to summarize patient demographics, clinical disease characteristics, infusion procedure variables and AEs for the ITT population. Controls were limited to available historic data from the SaROD study.The frequencies and proportions of IRRs for the primary outcome were summarized descriptively. The 95% confidence intervals were calculated for IRR proportions; exact methods were used as necessary. Descriptive statistics and 95% confidence intervals for the mean were calculated for the PROs. PRO data were not available for the historical controls. When applicable, pre‐post infusion comparisons of PROs were performed. For continuous or scale outcomes, paired 