12. Women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) and sexually active men must agree to use 2 acceptable contraceptive methods during this study. One of the 2 methods of birth control must be a condom. Acceptable methods of birth control in combination with condoms include diaphragm, birth control pills, injections, intrauterine device, and/or under-the-skin implants. Men and women must agree to maintain effective contraception for up to 3 months after the last dose of drug is administered.