- Subject, if female, must have a negative serum pregnancy test at screening. All subjects must be instructed to and agree to avoid pregnancy during the study and must be using an acceptable method of birth control: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 30 days prior to screening and will continue its use throughout the study and for 30 days following study participation. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study. Abstinence.