1. ACASI Questionnaire Schedule - Oral
Visit
Visit Code
ACASI Questionnaire to administer
Administer to:
Enrollment
3.0
All participants enrolled
Month 3*
6.0
First Quarterly Oral
All participants randomized to oral arm (unless product continuously held/discontinued past 4 weeks)
Months 6, 9, 15, 18, 21, 27, 30
9.0, 12.0, 18.0, 21.0, 24.0, 30.0, 33.0
Regular Quarterly Oral
Months 12, 24, and PUEV/Early Termination
15.0, 27.0, visit code associated with study month when PUEV/Early Termination occurs**
Annual/PUEV Oral
All participants randomized to oral arm who are completing an annual visit, scheduled PUEV, or early termination visit (unless product continuously held/discontinued past 4 weeks)
Study Exit (SEV) or any quarterly or semiannual visit where participant has been on
continuous product hold/ discontinuation for the past 4 weeks
89.0, visit code associated with study month when quarterly or semiannual visit occurs**
Product Hold/
Discontinuers/SEV
Participants randomized to oral arm who are completing a scheduled SEV, who have had product continuously held by site staff for 4 weeks or more, or who have permanently discontinued study product (site or participant choice) 4 or more weeks ago
* If participant misses her Month 3 Visit, administer the First Quarterly Oral ACASI questionnaire at the first quarterly visit she completes.
**Refer to SSP Section Table 14-2 for the list of visit codes assigned to each study visit

2. ACASI Questionnaire Schedule - Vaginal
Visit
Visit Code
ACASI Questionnaire to administer
Administer to:
Enrollment
3.0
All participants enrolled
Month 3*
6.0
First Quarterly Vaginal
All participants randomized to vaginal arm (unless product continuously held/discontinued past 4 weeks)
Months 6, 9, 15, 18, 21, 27, 30
9.0, 12.0, 18.0, 21.0, 24.0, 30.0, 33.0
Regular Quarterly Vaginal
Months 12, 24, and PUEV/Early Termination
15.0, 27.0, visit code associated with study month when PUEV/Early Termination occurs**
Annual/PUEV Vaginal
All participants randomized to vaginal arm who are completing an annual visit, scheduled PUEV, or early termination visit (unless product continuously held/discontinued past 4 weeks)
Study Exit (SEV) or any quarterly or semiannual visit where participant has been on
continuous product hold/ discontinuation for the past 4 weeks
89.0, visit code associated with study month when quarterly or semiannual visit occurs**
Product Hold/
Discontinuers/SEV
Participants randomized to vaginal arm who are completing a scheduled SEV, who have had product continuously held by site staff for 4 weeks or more, or who have permanently discontinued study product (site or participant choice) 4 or more weeks ago
* If participant misses her Month 3 Visit, administer the First Quarterly Vaginal ACASI questionnaire at the first quarterly visit she completes.
**Refer to SSP Section Table 14-2 for the list of visit codes assigned to each study visit