10.4. Appendix 4: Contraceptive Guidance
10.4.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements during
the intervention period and for at least 28 days after the last dose of study intervention, which
corresponds to the time needed to eliminate reproductive safety risk of the study
• Refrain from donating sperm.
• Be abstinent from heterosexual intercourse with a female of childbearing potential as
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and
agree to remain abstinent.
• Must agree to use a male condom when engaging in any activity that allows for
passage of ejaculate to another person.
• In addition to male condom use, a highly effective method of contraception may be
considered in WOCBP partners of male participants (refer to the list of highly
effective methods below in Section 10.4.4).
10.4.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at
least 1 of the following conditions applies:
• Is not a WOCBP (see definitions below in Section 10.4.3).
• Is a WOCBP and using an acceptable contraceptive method as described below
during the intervention period (for a minimum of 28 days after the last dose of study
intervention). The investigator should evaluate the effectiveness of the contraceptive
method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent
sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
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