About Clinical Research
Study #40421

Duration of required contraception for participants assigned female at birth and of childbearing potential enrolled in this clinical study should start from the screening visit until 60 days following administration of study drugs.

Participants assigned female at birth and of childbearing potential must agree to 1 of the following contraceptive methods:

• Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable method of contraception only when it is in line with the participant’s preferred and usual lifestyle.

Or

Consistent and correct use of 1 of the following methods of birth control listed below:

• Hormonal and nonhormonal intrauterine device
• Bilateral tubal occlusion (upon medical assessment of surgical success)
• Vasectomy in the partner assigned male at birth (upon medical assessment of surgical success)

Or

Participants assigned female at birth and of childbearing potential who initiate use of a hormonal contraceptive > 5 days after onset of menses as their method of birth control should use additional backup contraception (eg, condoms) for 7 days or avoid sexual intercourse for 7 days. Hormonally based contraceptives or barrier methods permitted for use in this protocol are as follows:

• Hormonal methods
 Oral contraceptives (either combined or progesterone only)
 Injectable progesterone
 Subdermal contraceptive implant
 Transdermal contraceptive patch
 Contraceptive vaginal ring
Or

• Barrier methods
 Male condom (with or without spermicide)
 Female condom (with or without spermicide)
 Diaphragm with spermicide
 Cervical cap with spermicide
 Sponge with spermicide

Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a participant assigned female at birth of any age.