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The 1 mg arm of Phase 2 produced direct measurement
This is a long-standing practice in medicine, often used when a patient has an allergy to a specific dye in a branded pill or when a commercially available drug is in short supply
Following the controversy regarding the potential increase in cardiovascular risk associated with thiazolidinedione therapy, regulatory authorities now require large studies to demonstrate the cardiovascular safety of newly developed glucose-lowering medications
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