a nonsignificant trendP = .06
When pooling in respect to single or multiple‐dose administration, there was a nonsignificant trend towards more subjects in the multiple‐dose groups with at least 1 related systemic AE ( P = .06).
When pooling in respect to single or multiple‐dose administration, there was a nonsignificant trend towards more subjects in the multiple‐dose groups with at least 1 related systemic AE ( P = .06).
Results from AUC 0‐24h suggest that a steady state exposure was reached in this dose range, with no relevant accumulation upon repeated daily dosing, because mean accumulation ratios did not reach statistical significance.