Trial Outcomes & Findings for HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women (NCT NCT01315353)

NCT ID: NCT01315353

Last Updated: 2018-05-11

Results Overview

The Kaplan-Meier estimate of the cumulative rate of CIN2+ (CIN2, CIN3 or invasive cancer) by week 130. Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN2+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 467 participants
• Primary outcome timeframe: Weeks 26, 52, 78, 104 and 130 post randomization
• Results posted on: 2018-05-11

Participant Flow

Participants were enrolled from April 2012 to June 2014 from 7 different countries.

Participant milestones

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Overall Study STARTED	145	143	179
Overall Study COMPLETED	116	120	166
Overall Study NOT COMPLETED	29	23	13

Reasons for withdrawal

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Overall Study Death	2	1	0
Overall Study Withdrawal by Subject	2	6	1
Overall Study Lost to Follow-up	13	6	6
Overall Study Unwilling to adhere to requirements	5	5	4
Overall Study Site closing	7	4	0
Overall Study Taken off study by site in error	0	1	0
Overall Study Inadvertent randomization/assignment	0	0	2

Baseline Characteristics

Includes participants with non-missing entry CD4+ T-cell counts.

Baseline characteristics by cohort

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B n=177 Participants Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Total n=465 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=145 Participants	0 Participants n=143 Participants	0 Participants n=177 Participants	0 Participants n=465 Participants
Age, Categorical Between 18 and 65 years	145 Participants n=145 Participants	143 Participants n=143 Participants	175 Participants n=177 Participants	463 Participants n=465 Participants
Age, Categorical >=65 years	0 Participants n=145 Participants	0 Participants n=143 Participants	2 Participants n=177 Participants	2 Participants n=465 Participants
Age, Continuous	38 years n=145 Participants	34 years n=143 Participants	36 years n=177 Participants	36 years n=465 Participants
Sex: Female, Male Female	145 Participants n=145 Participants	143 Participants n=143 Participants	177 Participants n=177 Participants	465 Participants n=465 Participants
Sex: Female, Male Male	0 Participants n=145 Participants	0 Participants n=143 Participants	0 Participants n=177 Participants	0 Participants n=465 Participants
Race/Ethnicity, Customized Black Non-Hispanic	106 Participants n=145 Participants	107 Participants n=143 Participants	156 Participants n=177 Participants	369 Participants n=465 Participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	11 Participants n=145 Participants	9 Participants n=143 Participants	6 Participants n=177 Participants	26 Participants n=465 Participants
Race/Ethnicity, Customized Asian, Pacific Islander	28 Participants n=145 Participants	27 Participants n=143 Participants	15 Participants n=177 Participants	70 Participants n=465 Participants
Region of Enrollment Haiti	3 Participants n=145 Participants	3 Participants n=143 Participants	16 Participants n=177 Participants	22 Participants n=465 Participants
Region of Enrollment Malawi	35 Participants n=145 Participants	37 Participants n=143 Participants	23 Participants n=177 Participants	95 Participants n=465 Participants
Region of Enrollment Botswana	8 Participants n=145 Participants	7 Participants n=143 Participants	45 Participants n=177 Participants	60 Participants n=465 Participants
Region of Enrollment South Africa	40 Participants n=145 Participants	41 Participants n=143 Participants	55 Participants n=177 Participants	136 Participants n=465 Participants
Region of Enrollment Zimbabwe	20 Participants n=145 Participants	19 Participants n=143 Participants	17 Participants n=177 Participants	56 Participants n=465 Participants
Region of Enrollment Peru	11 Participants n=145 Participants	9 Participants n=143 Participants	6 Participants n=177 Participants	26 Participants n=465 Participants
Region of Enrollment India	28 Participants n=145 Participants	27 Participants n=143 Participants	15 Participants n=177 Participants	70 Participants n=465 Participants
CD4+ T-cell Count	529 cells/mm^3 n=108 Participants • Includes participants with non-missing entry CD4+ T-cell counts.	479 cells/mm^3 n=106 Participants • Includes participants with non-missing entry CD4+ T-cell counts.	568 cells/mm^3 n=146 Participants • Includes participants with non-missing entry CD4+ T-cell counts.	521 cells/mm^3 n=360 Participants • Includes participants with non-missing entry CD4+ T-cell counts.
Nadir CD4+ T-Cell Count <=50 cells/mm^3	16 Participants n=134 Participants • Included participants with non-missing nadir CD4+ T-cell count.	15 Participants n=135 Participants • Included participants with non-missing nadir CD4+ T-cell count.	13 Participants n=167 Participants • Included participants with non-missing nadir CD4+ T-cell count.	44 Participants n=436 Participants • Included participants with non-missing nadir CD4+ T-cell count.
Nadir CD4+ T-Cell Count 51-100 cells/mm^3	12 Participants n=134 Participants • Included participants with non-missing nadir CD4+ T-cell count.	19 Participants n=135 Participants • Included participants with non-missing nadir CD4+ T-cell count.	17 Participants n=167 Participants • Included participants with non-missing nadir CD4+ T-cell count.	48 Participants n=436 Participants • Included participants with non-missing nadir CD4+ T-cell count.
Nadir CD4+ T-Cell Count 101-200 cells/mm^3	33 Participants n=134 Participants • Included participants with non-missing nadir CD4+ T-cell count.	34 Participants n=135 Participants • Included participants with non-missing nadir CD4+ T-cell count.	34 Participants n=167 Participants • Included participants with non-missing nadir CD4+ T-cell count.	101 Participants n=436 Participants • Included participants with non-missing nadir CD4+ T-cell count.
Nadir CD4+ T-Cell Count 201-500 cells/mm^3	61 Participants n=134 Participants • Included participants with non-missing nadir CD4+ T-cell count.	57 Participants n=135 Participants • Included participants with non-missing nadir CD4+ T-cell count.	70 Participants n=167 Participants • Included participants with non-missing nadir CD4+ T-cell count.	188 Participants n=436 Participants • Included participants with non-missing nadir CD4+ T-cell count.
Nadir CD4+ T-Cell Count >500 cells/mm^3	12 Participants n=134 Participants • Included participants with non-missing nadir CD4+ T-cell count.	10 Participants n=135 Participants • Included participants with non-missing nadir CD4+ T-cell count.	33 Participants n=167 Participants • Included participants with non-missing nadir CD4+ T-cell count.	55 Participants n=436 Participants • Included participants with non-missing nadir CD4+ T-cell count.
HIV-1 RNA <LLQ	93 Participants n=145 Participants	85 Participants n=143 Participants	116 Participants n=177 Participants	294 Participants n=465 Participants
HIV-1 RNA >=LLQ	52 Participants n=145 Participants	58 Participants n=143 Participants	61 Participants n=177 Participants	171 Participants n=465 Participants
Antiretroviral Therapy (ART) Use Not taking any ART	25 Participants n=145 Participants	22 Participants n=143 Participants	35 Participants n=177 Participants	82 Participants n=465 Participants
Antiretroviral Therapy (ART) Use Taking any ART	120 Participants n=145 Participants	121 Participants n=143 Participants	142 Participants n=177 Participants	383 Participants n=465 Participants

PRIMARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Analysis was limited to the two randomized study arms (Arms A and B).

The Kaplan-Meier estimate of the cumulative rate of CIN2+ (CIN2, CIN3 or invasive cancer) by week 130.

Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN2+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130	24.9 Events per 100 persons Interval 16.9 to 32.9	26.5 Events per 100 persons Interval 18.3 to 34.7	—

SECONDARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Intent to treat: All eligible participants were included in the analysis. Analysis was limited to the two randomized study arms (Arms A and B).

Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. The 10th percentile of the time to CIN2+ (the number of weeks at which 10% of participants had had CIN2+ diagnosis) is presented in the data table below.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Time to CIN2+ Diagnosis by Biopsy, as Determined by Local Review at a DAIDS-assessed Laboratory.	31 weeks Interval 28.0 to 66.0	30 weeks Interval 27.0 to 87.0	—

SECONDARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Intent-to-treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Analysis was limited to the two randomized study arms (Arms A and B).

The Kaplan-Meier estimate of the cumulative rate of CIN3+ (CIN3 or invasive cancer) by week 130.

Time to CIN3+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN3+ was first detected. For those who did not develop CIN3+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN3+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Cumulative Rate of CIN3+ (CIN3 or Invasive Cancer) by Week 130.	12.7 Cumulative rate of events/100 persons Interval 6.8 to 18.6	17.1 Cumulative rate of events/100 persons Interval 10.0 to 24.3	—

SECONDARY outcome

Timeframe: 0 to 130 weeks post randomization

Population: Intent to treat: All eligible participants were included in the analysis. Analysis was limited to the two randomized study arms (Arms A and B).

The number of participants who did not complete the study.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Number of Participants Who Discontinued Study Early.	29 Participants	23 Participants	—

SECONDARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Included participants with available cytology results.

Number of participants with abnormal (ASCUS: atypical squamous cells; undetermined significance, ASC-H: atypical squamous cells; favor high-grade squamous intra-epithelial lesion, LSIL: low-grade squamous intraepithelial lesion/mild dysplasia/HPV, HSIL: high-grade squamous intraepithelial lesion/moderate or severe dysplasia/carcinoma in situ/features of invasion; squamous cell carcinoma) cytology results.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Number of Participants With Abnormal Cytology Results at Study Visits. Week 26: With Abnormal Cytology	80 Participants	75 Participants	—
Number of Participants With Abnormal Cytology Results at Study Visits. Week 52: With Abnormal Cytology	80 Participants	72 Participants	—
Number of Participants With Abnormal Cytology Results at Study Visits. Week 78: With Abnormal Cytology	63 Participants	64 Participants	—
Number of Participants With Abnormal Cytology Results at Study Visits. Week 104: With Abnormal Cytology	57 Participants	62 Participants	—
Number of Participants With Abnormal Cytology Results at Study Visits. Week 130: With Abnormal Cytology	33 Participants	46 Participants	—

SECONDARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Includes participants with results for Abbott Real Time high-risk HPV assay

Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Abbott Real Time high-risk HPV assay. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=122 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=111 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Number of Participants With High Risk (hr)-HPV by the Abbott Real Time High-risk HPV Assay (aHPV) at Study Visits. Week 26: With hr-HPV Detected	74 Participants	78 Participants	—

SECONDARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Includes participants with results for Xpert HPV assay

Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Xpert HPV assay. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=119 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=109 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Number of Participants With High Risk (hr)-HPV by the Xpert HPV Assay at Study Visits. Week 26: With hr-HPV Detected	64 Participants	68 Participants	—

SECONDARY outcome

Timeframe: Weeks 26, 52, 78, 104 and 130 post randomization

Population: Includes participants with results for the Roche Linear Array HPV Genotyping test.

Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Roche Linear Array HPV Genotyping test. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=92 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=91 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Number of Participants With High Risk (hr)-HPV by the Roche Linear Array HPV Genotyping Test at Study Visits. Week 26: With hr-HPV Detected	74 Participants	73 Participants	—

SECONDARY outcome

Timeframe: 4 weeks post cryotherapy

Population: Included Arm A participants who had cryotherapy.

Cryotherapy was performed in Arm A within 7 days of study entry. Targeted AEs four weeks after cryotherapy is provided in the data table below. The AE categories are not mutually exclusive. A participant may have experienced AEs and may be counted in more than one category.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=142 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mild Odour	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mild P.V. Spotting	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mild Vaginal Bleeding	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Profuse watery vaginal discharge	20 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mild cervical bleeding	15 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Heavy odorous discharge	13 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Cervical infection	5 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mild watery vaginal discharge	4 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Lower Abdominal Pain	3 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Severe cramps or abdominal pain requiring parenter	3 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Moderate Watery Vaginal Discharge	2 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Pelvic inflammatory disease	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Abdominal Pain, Mild, No Medicine Taken	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Had Intermittent Blood Spotting Per Vagina	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Heavy cervical bleeding	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Light Watery Vaginal Discharge	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mild Vaginal Bleeding Moderate Watery Vaginal Disc	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Minimal Watery Discharge	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Mod Watery Non Offensive Vag Discharge & Mod Yello	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Moderate Offensive Vaginal Watery Discharge	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Moderate Vaginal Discharge	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Moderate Vaginal Watery Discharge And Minimal Yell	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Moderate Vaginal Discharge & Minimal Yellowi	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Post Coital Bleeding	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Moderate Vaginal Watery & Brown Smelly Discharge	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Slight Pv Discharge	1 percentage of participants	—	—
Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. Trichomonas Vaginitis	1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 4 weeks post LEEP

Population: Participants in each arm who had LEEP were included in the analysis.

LEEP was performed on participants who had CIN2+. For Arm A participants, LEEP was available starting at week 26; for Arms B and C, LEEP was available starting at study entry. Targeted AEs four weeks after LEEP is provided in the data table below. The AE categories are not mutually exclusive. A participant may have experienced AEs and may be counted in more than one category.

Outcome measures

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=24 Participants Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=34 Participants Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C : Ineligible for Randomization to Arm A or B n=54 Participants Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Percentage of Participants With Targeted AEs Reported Post LEEP. Cervical infection	0 percentage of participants	3 percentage of participants	2 percentage of participants
Percentage of Participants With Targeted AEs Reported Post LEEP. Metrorrhagia	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Targeted AEs Reported Post LEEP. Cervical bleeding	50 percentage of participants	21 percentage of participants	22 percentage of participants
Percentage of Participants With Targeted AEs Reported Post LEEP. Vaginal discharge	12 percentage of participants	15 percentage of participants	31 percentage of participants
Percentage of Participants With Targeted AEs Reported Post LEEP. Cramps or abdominal pain requiring parenteral meds	12 percentage of participants	6 percentage of participants	13 percentage of participants
Percentage of Participants With Targeted AEs Reported Post LEEP. Vaginal Bleeding	4 percentage of participants	3 percentage of participants	13 percentage of participants
Percentage of Participants With Targeted AEs Reported Post LEEP. Pelvic inflammatory disease	0 percentage of participants	3 percentage of participants	0 percentage of participants

Adverse Events

Arm A: Immediate Cryotherapy (HPV Test-and-treat)

Serious events: 5 serious events

Other events: 60 other events

Deaths: 2 deaths

Arm B: Cytology-based Strategy

Serious events: 2 serious events

Other events: 49 other events

Deaths: 1 deaths

Arm C: Ineligible for Randomization to Arm A or B

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 participants at risk Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 participants at risk Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C: Ineligible for Randomization to Arm A or B n=177 participants at risk Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Infections and infestations Localised infection	0.69% 1/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.69% 1/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.70% 1/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.69% 1/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.56% 1/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.69% 1/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.70% 1/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Reproductive system and breast disorders Cervical dysplasia	0.69% 1/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.56% 1/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Reproductive system and breast disorders Cervix haemorrhage uterine	0.00% 0/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.56% 1/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	0.00% 0/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	1.1% 2/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.

Other adverse events

Measure	Arm A: Immediate Cryotherapy (HPV Test-and-treat) n=145 participants at risk Participants in Arm A (HPV test-and-treat) had cervical cryotherapy at entry. Post entry, participants in Arm A were seen at regular intervals for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. Cervical Cryotherapy: Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy post-entry had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm B: Cytology-based Strategy n=143 participants at risk Participants in Arm B followed a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed). Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.	Arm C: Ineligible for Randomization to Arm A or B n=177 participants at risk Participants were eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C had colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP was performed and a follow-up visit 26 weeks after these procedures was scheduled for the collection of cervical specimens, cytology, and as needed, cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants went off study. Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy at any point during the study had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Gastrointestinal disorders Abdominal pain lower	9.7% 14/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	2.1% 3/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	1.7% 3/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Infections and infestations Bacterial vaginosis	17.2% 25/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	18.9% 27/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	5.1% 9/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Infections and infestations Cervicitis	20.0% 29/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	14.0% 20/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	15.3% 27/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Infections and infestations Cervicitis trichomonal	6.2% 9/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	3.5% 5/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	1.1% 2/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Infections and infestations Vulvovaginal candidiasis	6.2% 9/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	7.0% 10/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	1.7% 3/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Pregnancy, puerperium and perinatal conditions Pregnancy	6.2% 9/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	5.6% 8/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	1.7% 3/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Reproductive system and breast disorders Cervical dysplasia	8.3% 12/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	9.1% 13/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	10.2% 18/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Reproductive system and breast disorders Vaginal discharge	26.9% 39/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	10.5% 15/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	8.5% 15/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.
Reproductive system and breast disorders Vaginal haemorrhage	6.9% 10/145 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	2.1% 3/143 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.	2.8% 5/177 • AEs reported from entry visit to off study visit (at week 130 or earlier). At entry, all signs/symptoms (s/s) and lab values Grade \>=3 that occurred within 45 days prior to entry were recorded; post entry, s/s and lab values Grade \>=3 were recorded. Post entry, all grades of s/s related to cervical cryotherapy or LEEP treatments included in Addendum 1 were reported. SUSAR Reporting Category in DAIDS EAE Manual V2.0 was used. Grading was based on DAIDS AE Grading Table (V1.0) and Addendum 1.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
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