 - Specific contraception requirements for females: female subjects of childbearing potential must not become pregnant and are required to be sexually inactive by abstinence or use contraceptive methods with a failure rate of 1; sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject; periodic abstinence e.g. calendar, ovulation, symptothermal, post ovulation methods and withdrawal are not acceptable methods of contraception; contraceptive methods with a failure rate of 1 include the following: 