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Patients were at least 40 years of age, had A1C ≥ 6.5%, and multiple risk factors (21% of randomized patients) for cardiovascular disease (age ≥ 55 years for men and ≥ 60 years for women plus at least one additional risk factor of dyslipidemia, hypertension, or current cigarette smoking) or established (79% of the randomized patients) cardiovascular disease defined as a history of ischemic heart disease, peripheral vascular disease, or ischemic stroke