Safety monitoring
dysrhythmia, cardiac complications
MYOCARDIAL INFARCTION, ADVERSE EVENTS, CARDIAC ARREST, DYSRHYTHMIA, ASYMPTOMATIC BRADYCARDIA, CARDIAC COMPLICATIONS
This phase II study focused on safety and efficacy. Safety parameters collected throughout the study included cardiac complications such as dysrhythmia (e.g., symptomatic bradycardia), myocardial infarction, cardiac arrest, and neuro-worsening. All serious, unexpected, and study-related adverse events were reported in a blinded fashion to the Data Safety Monitoring Board within 24 h.