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For overweight hypertensive patients, an 8-kg weight loss can result in 8.5 mm Hg SBP and 6.5 mm Hg DBP decreases
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Post hoc sample size calculations were performed to guide recruitment efforts
FDA proposes to consider these criteria and the risks and benefits to patients of the compounded drug product or category of drug products in determining whether to add the drug product or category of drug products to one or both lists
