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Hospital practitioners and pharmacists compounding or preparing therapeutic goods for treatment at public hospitals are generally exempt, and specific exemptions apply to persons or institutions handling therapeutic goods in the context of approved clinical trials or for immediate, localised administration

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The FDA clinical studies were focused around correction of moderate to severe facial wrinkles and folds, such as nasolabial folds in adults over the age of 21

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PubMed Bornstein, N.M., Guekht, A., Vester, J., Heiss, W.D., Gusev, E., Hmberg, V., Rahlfs, V.W., Bajenaru, O., Popescu, B.O., & Muresanu, D