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FDA nonclinical toxicology review (2023-2024) flagged DNA damage in pituitary cells and injection-site necrosis in animal studies, plus immunogenicity and impurity risks from compounded material, alongside GH/IGF-1-axis effects such as fluid retention, joint discomfort, flushing, and headache reported by users

Briefly, PBMCs (5 10 5 cells/well) were cultured in 200 uL RPMI-1640 medium/10%FBS containing R848 (1 g/mL) and rIL2 (10 ng/mL, Mabtech, Nacka Strand, Sweden) with or without L-Cn (10 mg/mL) for 5 days in a round-bottomed 96-well plate