6. The effects of AR-67 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential (i.e., not post-menopausal for at least 12 months and not surgically sterile) and men must agree to use effective methods of contraception. Women of childbearing potential (any women who is not surgically sterile or > 2 years post menopause) must give consent for using a reliable method of contraception (e.g. double-barrier, tubal ligation or stable hormonal contraception) throughout the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.