 - male volunteers must agree to sexual abstinence or use adequate contraception when sexually active in combination with their female partners, if they are of childbearing potential. That means the volunteer must be vasectomized or use a condom and his female partner must either be surgically sterile hysterectomy or tubal ligation or agree to use a reliable method of contraception with a failure rate of less than 1 per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, or non-DalKon Shield intra-uterine devices IUDs. This applies from signing of the informed consent form until 90 days after the last study drug administration. Methods of contraception must have been effective for at least 30 days on the day of signing the informed consent form. Male volunteers must also refrain from sperm donation from signing of the informed consent form until 90 days after the last study drug administration; 