8. Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Women who are postmenopausal for at least 1 year (defined as > 12 months since last menses) or are surgically sterilized do not require this test. Women of child-bearing potential and their male partners must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of RH-1. Adequate methods of contraception are double barrier methods (condoms with spermicidal jelly or foam, and diaphragm with spermicidal jelly or foam), oral, depot and injectable contraceptives, and intrauterine device (IUD). RH-1 should not be administered to women who are breast feeding.