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In the action in diabetes and vascular disease (ADVANCE) trial, a study involving 11,140 subjects with T2DM who were followed for a median duration of 4.4 years, a higher HR was associated with a significantly increased risk of all-cause mortality, cardiovascular death, and major cardiovascular events (death, nonfatal acute myocardial infarction [AMI] or nonfatal stroke) [39]

The primary endpoint was measured at 52 weeks, and patients continued treatment for 104 weeks or until the study was completed