Statistical tests
death, seizures, seizure
EVENT
The primary efficacy endpoint (6‐month failure rate) will be assessed using a chi‐square test with continuity correction on the significance level of 5% (two‐sided). Twelve‐ and 18‐month failure rates will be assessed using the same approach as for the primary efficacy endpoint. Time to event (i.e., time to first unprovoked seizure) analyses will be assessed using Kaplan–Meier methodology. Cause‐specific cumulative incidence curves will evaluate the competing risk in case of death before the first unprovoked seizure. Descriptive statistics will be used to summarize the number of acute symptomatic seizures, the number and 4‐week rate of unprovoked seizures, and results for the Barthel Index, NIHSS, and PHQ‐9. Demographic and baseline characteristics, safety assessments and the exploratory endpoint will be summarized using descriptive statistics.