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Seefeldt T, Zhao Y, Chen W, Raza AS, Carlson L, Herman J, et al
Critically, AOD-9604 did not produce the metabolic side effects associated with full-length growth hormone, including no insulin resistance or glucose intolerance, no elevation of IGF-1 levels, no fluid retention or joint pain, and no cardiovascular parameter changes
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For sterile products, FDA expects manufacturers to demonstratenot assumethat contamination risks are effectively controlled
Hong, J
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