 - Female subjects of childbearing potential includes women who are less than 1 year postmenopausal and women who become sexually active during the study must be using an acceptable method of birth control eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide or be surgically sterilized eg, hysterectomy or tubal ligation, and must continue such precautions for 6 months after receiving the last study agent infusion, and have a negative serum pregnancy test prior to enrollment. Additionally, male subjects who are sexually active, with women of childbearing potential, should ensure that they or their partners are using adequate contraception 