AE profile
death, sudden death
SUDDEN DEATH, ADVERSE EVENT
Safety was consistent with previous reportsSafety summary (safety analysis set).AE: adverse event; CI: confidence interval; EAIR: exposure adjusted incidence rate per 100 patient years; SAE: serious adverse event.Preferred terms are according to MedDRA version 24.1.Data from the safety analysis set.Data are from the core period.Data from both the core and open-label extension periods.Causes of death were: sudden death (