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In contrast, blood glucose level of 54 mg/dL or less occurred in 6% of patients receiving the 14 mg tablets, 3% of patients receiving placebo, and 0% of patients receiving the 7 mg tablets

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The device to be included in the new category must Not be appropriately described by an existing category or by any category previously in effect established for transitional pass-through payments, and was not being paid for as an outpatient service as of December 31, 1996