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In explaining its decision, the agency flagged concerns about complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization, the potential for aggregation and a lack of human safety data

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Research suggests that fracture patients need 1.5 to 2.0 grams of protein per kilogram of body weight per day during active healing, significantly more than the general recommendation of 0.8 grams per kilogram

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