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To assess potential effect modification, we calculated P -values for interaction using the likelihood ratio test, comparing models with and without the interaction term

Signs of contamination or degradation: Cloudiness or turbidity (potential bacterial growth or precipitation) Visible particles or crystals (potential contamination or degradation products) Discolouration or browning (potential oxidative degradation) Visible mould growth (rare, but indicates severe contamination) Unpleasant or unusual odour (potential bacterial contamination) Action: If any of these signs are observed, discard the vial immediately