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Abstract Aims/hypothesis Simultaneous control of HbA 1c , lipid profile, BP and body weight is essential for preventing chronic complications of type 2 diabetes

N Engl J Med 2009

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As part of this process, they must submit information about chemistry, manufacturing, and controls (CMC): How the active ingredient is made, what the manufacturer proposes as specifications for quality, and tests it will use to assure the product meets specifications