 1. Use of any new medication, including multi-vitamins, or an investigational drug within 14 days prior to the drug administration, or within five times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days and Vitamin K supplements and thiamine for hepatic impairment subjects; any local anesthetic within 3 days before study drug administration. Current over-the-counter OTC and prescription medication use is permitted, but must be stable and consistent for at least 14 days prior to screening and throughout the study treatment period. 