 19. The use of prohibited medications, including prescription, over the counter OTC medications, herbal medications, inducers or inhibitors of CYP450 enzymes or drug transporters including P-gp within 14 days prior to the first dose of study medication is excluded, unless previously approved by the Sponsors Medical Monitor. NOTE: Chronic medication use is permitted so long as they are medically necessary, deemed acceptable by the Principal Investigator and Medical Monitor, and not Prohibited Medications see Section 5.12. 