During the study a total of 18 serious adverse events (sAE) were reported, 9 during the screening/run-in phase and 9 during the 12 week randomization period. There were 3 sAE in each of the placebo and 2.0mg BRL 49653 groups and I in each of the 0.05, 0.25 and 1.0mg groups. There were 2 deaths during the study, one case of myocardial infarction (2.0mg group) in a 52 year old male was designated as possibly related, and the other case (0.25mg group), a 71 year old male with cardiopulmonary arrest, was unrelated. All other sAE were specified by the investigators as being unrelated to trial medication, apart from 1 case of exercise induced non-sustained ventricular tachycardia in a 56 year old male receiving placebo. Causal relationship was given as possibly related in this case.