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In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events, such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur

Standard laboratory tools, accurate micro-pipettes, and sterile bacteriostatic water are sufficient for correct reconstitution and measurement

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Safety and Pharmacology Evaluations : Conducting preclinical toxicology, pharmacokinetic, and receptor-binding studies to characterize how AOD 9604 is handled in vivo and confirm it does not activate growth hormone-like proliferative pathways