 11. Females of childbearing potential with a negative serum beta-Human chorionic gonadotropin or a negative urine pregnancy test at Visit 1 Screening and prior to starting study drugs Visit 3. Female participants of childbearing potential who agreed to be abstinent or to use a highly effective method of contraception eg, condom spermicide, condom diaphragm with spermicide, intrauterine device IUD, or have a vasectomised partner starting prior to starting study drug, throughout the entire study period and for 30 days after the last dose of study drug. Those women using hormonal contraceptives must also have used an additional approved method of contraception as described previously. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential 