Despite a large sample size, the event rate in the study was lower than anticipated. Aspirin was well tolerated in these patients, as there was no increase in hemorrhagic strokes and a small increase in serious GI hemorrhagic events (4 patients required transfusion). These findings should be interpreted in context with the low incidence of atherosclerotic disease in Japan and the current management practice for cardiovascular risk factors and suggest the need to conduct additional studies of aspirin for primary prevention of cardiovascular disease in diabetic patients.