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Full text: Karner, M., Kocjan, A., Stein, J., Schreiber, S., von Boyen, G., Uebel, P., Schmidt, C., Kupcinskas, L., Dina, I., Zuelch, F., Keilhauer, G., & Stremmel, W

analyses of safety endpoints were based on the safety analysis set (SAS), which included all participants exposed to at least one dose of trial product

Using MedDRA: implications for risk management