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Rarely, hypersensitivity reactions can occur, for instance, urticaria (hives) or other allergic-type reactions have been reported in isolated cases

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Without that, use is off-label and uncoupled from systematic safety monitoring

Human mutation, 13(5), 362375.[PubMed] [Wiley] Lalouschek, W., Aull, S., Serles, W., Schnider, P., Mannhalter, C., Lang, T., Deecke, L., & Zeiler, K