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However, translation to human therapies requires rigorous clinical trials to establish safety and efficacy

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Additional requirements can be imposed on a case-by-case basis, including collection of safety data using an Australian patient registry, enhanced communications to health care professionals and patients, more frequent or more prolonged submission of Periodic Benefit-Risk Evaluation Reports (PBRER) and possible selection of product for TGA laboratory testing

It packages some of the most well-studied recovery compounds into a single vial, making it approachable for people who are new to injectable peptides or want to simplify their protocol