 23. The female subject is pregnant, lactating breast feeding, or planning a pregnancy during the course of the study. Or, the female subject is of child-bearing potential and is not using a highly effective methods of birth control, including sexual abstinence. Or, the female subject is unwilling to continue using a highly-effective method of birth control throughout the duration of the study. Note: A highly effective method of birth control is defined as one that results in a low failure rate ie, less than one percent per year when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices IUDs, sexual abstinence, or a vasectomized partner. 