 - Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A CYP3A or cytochrome P450, family 2, subfamily C, polypeptide 8 CYP2C8 are ineligible; current use of, or intended ongoing treatment with: herbal remedies e.g., St. Johns wort, or strong inhibitors or inducers of P-glycoprotein Pgp or breast cancer resistance protein 1 Bcrp1 should also be excluded; it is important to regularly consult a frequently-updated list of these agents; as part of the enrollmentinformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product 