 In women of child-bearing potential, negative serum pregnancy test within 48 hours prior to day 1 of study treatment and agree to use effective contraception. Effective contraception is defined as: a an intrauterine device with a documented failure rate of less than 1 per year. b male partner sterilization prior to the female subjects entry, and this male is the sole sexual partner for that female. c complete abstinence from sexual intercourse for 14 days prior to enrollment throughout study treatment, and for at least 4 months after the last dose of study treatment. Abstinence is only acceptable when in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g. calendar ovulation, symptothermal, post-ovulation methods, etc and withdrawal are not acceptable methods of contraception. d double- barrier contraception: condom and occlusive cap diaphragm or cervicalvault caps with a vaginal spermicidal agent foamgelcreamsuppository. Note: hormonal based methods e.g. oral contraceptives are not permitted. 