Statistical Analyses
MRS, death, Neurological disability
EVENT, MRS
Analysis was performed in GraphPad Prismv.9.0 and Rv.3.6.0. The primary analysis was performed in the modified intention-to-treat population (received any dose of the study drug). A sensitivity analysis was planned for the per-protocol population (completed treatment as specified in the protocol). However, given the small sample size and since these populations were similar, here we report the most conservative analysis (modified intention-to-treat).The primary end point, frequency of AESI or death (data censored at the first event prior to day 56), was summarized and compared across arms using a χ2 test. A time-to-event analysis was performed for worst grade (in each individual participant) AESI or death; comparisons between study groups were made using the log-rank test. Neurological disability (MRS) and radiological outcomes at day 56 were compared across arms using a Details of further analysis can be found in the published statistical analysis plan [