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US FDA, Div Pharmaceut Evaluat 1 HFD 860, Off Clin Pharmacol & Biopharmceut, Woodmont Off Ctr 2, Rockville, MD 20852 USA US FDA, Div Pharmaceut Evaluat 1 HFD 860, Off Clin Pharmacol & Biopharmceut, Woodmont Off Ctr 2, Rockville, MD 20852 USA