The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement by Fusaroli, M, Salvo, F, Begaud, B, AlShammari, TM, Bate, A, Battini, V, Brueckner, A, Candore, G, Carnovale, C, Crisafulli, S, Cutroneo, PM, Dolladille, C, Drici, M, Faillie, J, Goldman, A, Hauben, M, Herdeiro, MT, Mahaux, O, Manlik, K, Montastruc, F, Noguchi, Y, Norén, GN, Noseda, R, Onakpoya, IJ, Sartori, D

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration by Fusaroli, M, Salvo, F, Begaud, B, AlShammari, TM, Bate, A, Battini, V, Brueckner, A, Candore, G, Carnovale, C, Crisafulli, S, Cutroneo, PM, Dolladille, C, Drici, M, Faillie, J, Goldman, A, Hauben, M, Herdeiro, MT, Mahaux, O, Manlik, K, Montastruc, F, Noguchi, Y, Norén, GN, Noseda, R, Onakpoya, IJ, Sartori, D