 15. Considered clinically stable in the opinion of the Investigator 16. Presence of mild renal impairment eGFR 60-89 mLmin1.73m2, moderate renal impairment eGFR 30-59 mLmin1.73m2, or severe renal impairment eGFR 30 mLmin1.73m2 calculated using MDRD equation at screening 