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FDA staff cited inconsistent naming, incomplete physical and chemical characterization, inadequate information about impurities and aggregates, limited historical compounding data, no clinical evidence supporting effectiveness for insomnia, insufficient human safety data, uncertain subcutaneous use, potential immunogenicity, and unresolved concern about long-term telomerase activation and carcinogenic risk

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This would include awarding 0, 1, 2, 3, and 4, measure performance scaler points across the 5 levels from bottom to top performance, respectively, to allow for more nuance in the distribution of performance across each of the current four domains