 - Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months i.e., who has had menses any time in the preceding 12 consecutive months, must have a negative serum pregnancy test 72 hours prior to initiating treatment 