 - Females of childbearing potential, unless surgically sterile ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy, had sterile male partner, were premenarchal or at least 2 years postmenopausal, or practiced abstinence, must have used 2 effective methods of avoiding pregnancy including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner for at least 30 days prior to dosing with investigational product, and must have agreed to continue using such precautions for at least 90 days after dosing with investigational product; cessation of birth control after this point was to be discussed with a responsible physician. The subject must also have had a negative serum or urine pregnancy test within 14 days prior to investigational product administration if screening and administration of investigational product did not occur on the same day and on the day of investigational product administration prior to randomization 