The trial was a multicenter, randomized, double-blind and parallel- designed study, conducted in five centers in the United States. Twenty-four CAA patients with lobar cerebral hemorrhage were randomized to receive 3 different daily doses of Cerebril (100, 200 and 300 mg) for a period of twelve weeks. The data showed no safety findings of concern based on patient's clinical laboratory tests, vital signs and electrocardiograms during follow-up physical exams. The most frequent adverse events, namely nausea and vomiting, were mild-to-moderate at all doses tested, and transient in the patients receiving 100mg or 200mg daily of Cerebril. Five patients withdrew prematurely: three because of nausea and vomiting and two because of expected complications of CAA.