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Food and Drug Administration (FDA) reviews the clinical trial information to determine if the benefits outweigh the risks

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These adverse reactions were not present at baseline, occurred more commonly on dapagliflozin and metformin HCl than on placebo, and occurred in at least 2% of patients treated with either dapagliflozin 5 mg or dapagliflozin 10 mg

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She beat her previous best time by .28 seconds