 - Female subjects of childbearing potential i.e., not surgically sterile andor not postmenopausal must be practicing adequate contraception i.e., meeting one of the criteria defined below from at least 14 days prior to the first dose of randomised study medication until the 12-week post-treatment Follow-up visit : Abstinence from penile-vaginal intercourse, when this is the females preferred and usual lifestyle; Oral Contraceptive, either combined or progestogen alone ; Injectable progestogen; Implants of etonogestrel or levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device or intrauterine system that has a failure rate of less than 1 per year when used consistently and correctly as stated in the product label; Male partner sterilization prior to the female subjects entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnels review of subjects medical records; medical examination of the subject andor semen analysis; or interview with the subject on his medical history.; Male condom combined with a female diaphragm, either with or without a vaginal spermicide 