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The first patient was enrolled on September 10, and the last patient concluded the study on May 4, Patients were excluded if they had a history of ketoacidosis or had unstable or rapidly progressive diabetic retinopathy, nephropathy, or neuropathy; impaired hepatic or renal function; or severe anemia. Patients with serious cardiovascular disease CVD or cerebrovascular conditions within 6 months before study enrollment were also excluded. Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions were also excluded. A description of how randomization and medication compliance were assessed can be found in our previous work. Before starting the study, all patients underwent an initial screening assessment that included a medical history, physical examination, vital signs, and a lead electrocardiogram.

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