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doi: 10.3233/BMR-170983

Therefore, although the applicant suggests otherwise, this data did not follow a statistical distribution similar to that considered for rarely-utilized orphan drugs meeting the criteria at 414.940(d)(5), which may not have a normal statistical distribution from quarter to quarter, potentially resulting in highly variable refund amounts as compared with the variability of drugs administered to a higher number of beneficiaries

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often compounded in clinics Australia : Originally developed and trialed

Human peptide trials have involved small sample sizes and, sometimes, loose protocols with no blinding or placebo controls