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An advantage of this approach is that the denominator would represent sales that are ultimately dispensed in retail community pharmacy settings and in outpatient settings (whereas, as mentioned previously, unit reporting under the MDRP represents units typically dispensed only in the retail community pharmacy setting)

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Review and approval was in accordance with the Department of Health and Human Services regulations in 45 CFR 46, including the Common Rule (subpart A) that provides protections for research subjects