Papilloma/ carcinoma of the preputial/ clitoral gland were noted from 30 mg/ kg/ day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/ day or 800 mg/ day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/ m2/ day.