Trial Outcomes & Findings for Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women (NCT NCT00705679)

NCT ID: NCT00705679

Last Updated: 2021-10-29

Results Overview

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5029 participants
• Primary outcome timeframe: For up to 30 months of follow-up
• Results posted on: 2021-10-29

Participant Flow

Women were recruited from September 2009 through June 2011 from 15 sites in South Africa, Uganda, and Zimbabwe.

12,320 women were assessed for eligibility and 7,291 were excluded for various reasons, including 2,308 women who were HIV-positive. 5,029 women were randomized.

Participant milestones

Measure	Oral TDF TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet	Oral TDF-FTC TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Overall Study STARTED	1007	1003	1009	1007	1003
Overall Study COMPLETED	942	864	894	927	934
Overall Study NOT COMPLETED	65	139	115	80	69

Reasons for withdrawal

Measure	Oral TDF TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet	Oral TDF-FTC TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Overall Study Adverse Event	1	1	0	0	0
Overall Study Death	0	0	3	2	1
Overall Study Lost to Follow-up	32	60	44	30	35
Overall Study Physician Decision	0	1	0	1	0
Overall Study Withdrawal by Subject	32	77	68	47	33

Baseline Characteristics

Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

Baseline characteristics by cohort

Measure	Oral TDF n=1007 Participants TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet	Oral TDF-FTC n=1003 Participants TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet	Oral Placebo n=1009 Participants TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel n=1007 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo n=1003 Participants Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel	Total n=5029 Participants Total of all reporting groups
Age, Continuous	25.5 years STANDARD_DEVIATION 5.1 • n=5 Participants	25.2 years STANDARD_DEVIATION 5.2 • n=7 Participants	25.3 years STANDARD_DEVIATION 5.2 • n=5 Participants	25.3 years STANDARD_DEVIATION 5.2 • n=4 Participants	25.3 years STANDARD_DEVIATION 5.1 • n=21 Participants	25.3 years STANDARD_DEVIATION 5.2 • n=8 Participants
Sex: Female, Male Female	1007 Participants n=5 Participants	1003 Participants n=7 Participants	1009 Participants n=5 Participants	1007 Participants n=4 Participants	1003 Participants n=21 Participants	5029 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Chichewa	4 participants n=5 Participants	10 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	2 participants n=21 Participants	30 participants n=8 Participants
Race/Ethnicity, Customized Lombwe	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized Yao	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	2 participants n=8 Participants
Race/Ethnicity, Customized Tumbuka	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	3 participants n=8 Participants
Race/Ethnicity, Customized Other African tribe	76 participants n=5 Participants	75 participants n=7 Participants	83 participants n=5 Participants	92 participants n=4 Participants	84 participants n=21 Participants	410 participants n=8 Participants
Race/Ethnicity, Customized White	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants
Race/Ethnicity, Customized Zulu	601 participants n=5 Participants	587 participants n=7 Participants	595 participants n=5 Participants	585 participants n=4 Participants	571 participants n=21 Participants	2939 participants n=8 Participants
Race/Ethnicity, Customized Xhosa	85 participants n=5 Participants	75 participants n=7 Participants	74 participants n=5 Participants	72 participants n=4 Participants	92 participants n=21 Participants	398 participants n=8 Participants
Race/Ethnicity, Customized Indian	21 participants n=5 Participants	28 participants n=7 Participants	22 participants n=5 Participants	22 participants n=4 Participants	22 participants n=21 Participants	115 participants n=8 Participants
Race/Ethnicity, Customized Colored	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants	1 participants n=21 Participants	11 participants n=8 Participants
Race/Ethnicity, Customized Black	64 participants n=5 Participants	64 participants n=7 Participants	65 participants n=5 Participants	65 participants n=4 Participants	64 participants n=21 Participants	322 participants n=8 Participants
Race/Ethnicity, Customized Bemba	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants
Race/Ethnicity, Customized Chewa	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	2 participants n=8 Participants
Race/Ethnicity, Customized Tonga	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants
Race/Ethnicity, Customized Lozi	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants
Race/Ethnicity, Customized Shona	123 participants n=5 Participants	108 participants n=7 Participants	111 participants n=5 Participants	111 participants n=4 Participants	117 participants n=21 Participants	570 participants n=8 Participants
Race/Ethnicity, Customized Ndebele	14 participants n=5 Participants	27 participants n=7 Participants	18 participants n=5 Participants	25 participants n=4 Participants	22 participants n=21 Participants	106 participants n=8 Participants
Race/Ethnicity, Customized Other	17 participants n=5 Participants	24 participants n=7 Participants	30 participants n=5 Participants	24 participants n=4 Participants	25 participants n=21 Participants	120 participants n=8 Participants
Region of Enrollment South Africa	816 participants n=5 Participants	812 participants n=7 Participants	815 participants n=5 Participants	818 participants n=4 Participants	816 participants n=21 Participants	4077 participants n=8 Participants
Region of Enrollment Uganda	64 participants n=5 Participants	64 participants n=7 Participants	65 participants n=5 Participants	65 participants n=4 Participants	64 participants n=21 Participants	322 participants n=8 Participants
Region of Enrollment Zimbabwe	127 participants n=5 Participants	127 participants n=7 Participants	129 participants n=5 Participants	124 participants n=4 Participants	123 participants n=21 Participants	630 participants n=8 Participants
Some secondary school education or higher Some secondary school education or higher	924 participants n=5 Participants	929 participants n=7 Participants	926 participants n=5 Participants	920 participants n=4 Participants	923 participants n=21 Participants	4622 participants n=8 Participants
Some secondary school education or higher Complete primary school education or lower	82 participants n=5 Participants	74 participants n=7 Participants	83 participants n=5 Participants	85 participants n=4 Participants	79 participants n=21 Participants	403 participants n=8 Participants
Some secondary school education or higher Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	4 participants n=8 Participants
Earns own income Yes	569 participants n=5 Participants	569 participants n=7 Participants	586 participants n=5 Participants	587 participants n=4 Participants	570 participants n=21 Participants	2881 participants n=8 Participants
Earns own income No	438 participants n=5 Participants	434 participants n=7 Participants	423 participants n=5 Participants	420 participants n=4 Participants	432 participants n=21 Participants	2147 participants n=8 Participants
Earns own income Missing	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants
Live births	1.6 children STANDARD_DEVIATION 1.1 • n=5 Participants	1.5 children STANDARD_DEVIATION 1.1 • n=7 Participants	1.5 children STANDARD_DEVIATION 1.2 • n=5 Participants	1.5 children STANDARD_DEVIATION 1.1 • n=4 Participants	1.5 children STANDARD_DEVIATION 1.2 • n=21 Participants	1.5 children STANDARD_DEVIATION 1.1 • n=8 Participants
Currently married Yes	207 participants n=5 Participants	209 participants n=7 Participants	211 participants n=5 Participants	210 participants n=4 Participants	215 participants n=21 Participants	1052 participants n=8 Participants
Currently married No	800 participants n=5 Participants	794 participants n=7 Participants	798 participants n=5 Participants	797 participants n=4 Participants	788 participants n=21 Participants	3977 participants n=8 Participants
At least 2 male sex partners in the past 3 months Yes	236 participants n=5 Participants	208 participants n=7 Participants	244 participants n=5 Participants	217 participants n=4 Participants	199 participants n=21 Participants	1104 participants n=8 Participants
At least 2 male sex partners in the past 3 months No	761 participants n=5 Participants	782 participants n=7 Participants	754 participants n=5 Participants	779 participants n=4 Participants	793 participants n=21 Participants	3869 participants n=8 Participants
At least 2 male sex partners in the past 3 months No response	10 participants n=5 Participants	13 participants n=7 Participants	11 participants n=5 Participants	11 participants n=4 Participants	11 participants n=21 Participants	56 participants n=8 Participants
Episodes of vaginal intercourse in the past 7 days	2.5 episodes STANDARD_DEVIATION 2.8 • n=5 Participants	2.5 episodes STANDARD_DEVIATION 3.4 • n=7 Participants	2.5 episodes STANDARD_DEVIATION 2.6 • n=5 Participants	2.6 episodes STANDARD_DEVIATION 3.6 • n=4 Participants	2.6 episodes STANDARD_DEVIATION 2.9 • n=21 Participants	2.5 episodes STANDARD_DEVIATION 3.1 • n=8 Participants
Condom use during last vaginal intercourse Yes	763 participants n=5 Participants	760 participants n=7 Participants	742 participants n=5 Participants	768 participants n=4 Participants	733 participants n=21 Participants	3766 participants n=8 Participants
Condom use during last vaginal intercourse No	242 participants n=5 Participants	239 participants n=7 Participants	263 participants n=5 Participants	239 participants n=4 Participants	268 participants n=21 Participants	1251 participants n=8 Participants
Condom use during last vaginal intercourse Missing	2 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants	12 participants n=8 Participants
Anal sex in the previous 3 months Yes	164 participants n=5 Participants	175 participants n=7 Participants	174 participants n=5 Participants	179 participants n=4 Participants	176 participants n=21 Participants	868 participants n=8 Participants
Anal sex in the previous 3 months No	827 participants n=5 Participants	812 participants n=7 Participants	823 participants n=5 Participants	814 participants n=4 Participants	810 participants n=21 Participants	4086 participants n=8 Participants
Anal sex in the previous 3 months Missing	16 participants n=5 Participants	16 participants n=7 Participants	12 participants n=5 Participants	14 participants n=4 Participants	17 participants n=21 Participants	75 participants n=8 Participants
Injectable contraception use Yes	709 participants n=5 Participants	723 participants n=7 Participants	700 participants n=5 Participants	707 participants n=4 Participants	726 participants n=21 Participants	3565 participants n=8 Participants
Injectable contraception use No	298 participants n=5 Participants	280 participants n=7 Participants	309 participants n=5 Participants	300 participants n=4 Participants	277 participants n=21 Participants	1464 participants n=8 Participants
Oral pills contraception Yes	226 participants n=5 Participants	223 participants n=7 Participants	238 participants n=5 Participants	238 participants n=4 Participants	215 participants n=21 Participants	1140 participants n=8 Participants
Oral pills contraception No	781 participants n=5 Participants	780 participants n=7 Participants	771 participants n=5 Participants	769 participants n=4 Participants	788 participants n=21 Participants	3889 participants n=8 Participants
Infection by Chlamydia trachomatis Yes	122 participants n=5 Participants	117 participants n=7 Participants	127 participants n=5 Participants	116 participants n=4 Participants	129 participants n=21 Participants	611 participants n=8 Participants
Infection by Chlamydia trachomatis No	884 participants n=5 Participants	886 participants n=7 Participants	882 participants n=5 Participants	891 participants n=4 Participants	874 participants n=21 Participants	4417 participants n=8 Participants
Infection by Chlamydia trachomatis Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants
Infection by Neisseria gonorrhoeae Yes	42 participants n=5 Participants	27 participants n=7 Participants	34 participants n=5 Participants	24 participants n=4 Participants	36 participants n=21 Participants	163 participants n=8 Participants
Infection by Neisseria gonorrhoeae No	964 participants n=5 Participants	976 participants n=7 Participants	975 participants n=5 Participants	983 participants n=4 Participants	967 participants n=21 Participants	4865 participants n=8 Participants
Infection by Neisseria gonorrhoeae Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants
Infection by Trichomonas vaginalis Yes	68 participants n=5 Participants	54 participants n=7 Participants	66 participants n=5 Participants	62 participants n=4 Participants	51 participants n=21 Participants	301 participants n=8 Participants
Infection by Trichomonas vaginalis No	939 participants n=5 Participants	948 participants n=7 Participants	943 participants n=5 Participants	943 participants n=4 Participants	949 participants n=21 Participants	4722 participants n=8 Participants
Infection by Trichomonas vaginalis Missing	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants	6 participants n=8 Participants
Syphilis infection Yes	12 participants n=5 Participants	15 participants n=7 Participants	16 participants n=5 Participants	14 participants n=4 Participants	11 participants n=21 Participants	68 participants n=8 Participants
Syphilis infection No	994 participants n=5 Participants	988 participants n=7 Participants	993 participants n=5 Participants	993 participants n=4 Participants	992 participants n=21 Participants	4960 participants n=8 Participants
Syphilis infection Missing	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants
HSV-2 infection Yes	482 participants n=5 Participants	449 participants n=7 Participants	455 participants n=5 Participants	438 participants n=4 Participants	465 participants n=21 Participants	2289 participants n=8 Participants
HSV-2 infection No	520 participants n=5 Participants	548 participants n=7 Participants	551 participants n=5 Participants	566 participants n=4 Participants	531 participants n=21 Participants	2716 participants n=8 Participants
HSV-2 infection Missing	5 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	7 participants n=21 Participants	24 participants n=8 Participants
Bacterial vaginosis infection Yes	422 participants n=5 Participants	410 participants n=7 Participants	401 participants n=5 Participants	397 participants n=4 Participants	393 participants n=21 Participants	2023 participants n=8 Participants
Bacterial vaginosis infection No	578 participants n=5 Participants	592 participants n=7 Participants	607 participants n=5 Participants	606 participants n=4 Participants	604 participants n=21 Participants	2987 participants n=8 Participants
Bacterial vaginosis infection Missing	7 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	19 participants n=8 Participants

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.

Outcome measures

Measure	TFV Gel n=996 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=996 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms	1024 person-years	1030 person-years	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).

Outcome measures

Measure	TFV Gel n=996 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=996 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms	61 participants	70 participants	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).

Outcome measures

Measure	TFV Gel n=996 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=996 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms	6.0 cases per 100 person-years Interval 4.6 to 7.6	6.8 cases per 100 person-years Interval 5.3 to 8.6	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.

Outcome measures

Measure	TFV Gel n=993 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=999 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Person-years of Follow-up of Oral TDF and Oral Placebo Arms	823 person-years	838 person-years	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).

Outcome measures

Measure	TFV Gel n=993 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=999 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms	52 participants	35 participants	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).

Outcome measures

Measure	TFV Gel n=993 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=999 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms	6.3 cases per 100 person-years Interval 4.7 to 8.3	4.2 cases per 100 person-years Interval 2.9 to 5.8	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.

Outcome measures

Measure	TFV Gel n=985 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=999 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms	1284 person-years	1308 person-years	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).

Outcome measures

Measure	TFV Gel n=985 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=999 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms	61 participants	60 participants	—	—	—

PRIMARY outcome

Timeframe: For up to 30 months of follow-up

Population: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).

Outcome measures

Measure	TFV Gel n=985 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=999 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms	4.7 cases per 100 person-years Interval 3.6 to 6.1	4.6 cases per 100 person-years Interval 3.5 to 5.9	—	—	—

PRIMARY outcome

Timeframe: Throughout study, up to 2.5 years

Population: All participants randomized (intention-to-treat).

This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.

Outcome measures

Measure	TFV Gel n=1007 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=1003 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo n=1009 Participants TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel n=1007 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo n=1003 Participants Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events	4 participants	13 participants	2 participants	9 participants	3 participants

SECONDARY outcome

Timeframe: Throughout study, up to 2.5 years

Population: Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure.

The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.

Outcome measures

Measure	TFV Gel n=58 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Placebo Gel n=55 Participants Application of placebo gel once daily Tenofovir placebo gel: placebo gel	Oral Placebo n=60 Participants TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel n=60 Participants Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo n=69 Participants Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product M184V mutation	0 participants	1 participants	0 participants	0 participants	0 participants
Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product No M184V mutation	58 participants	54 participants	60 participants	60 participants	68 participants

Adverse Events

Oral TDF

Serious events: 17 serious events

Other events: 646 other events

Deaths: 0 deaths

Oral TDF-FTC

Serious events: 42 serious events

Other events: 740 other events

Deaths: 0 deaths

Oral Placebo

Serious events: 57 serious events

Other events: 747 other events

Deaths: 0 deaths

TFV Gel

Serious events: 39 serious events

Other events: 705 other events

Deaths: 0 deaths

Gel Placebo

Serious events: 26 serious events

Other events: 715 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral TDF n=1007 participants at risk TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet	Oral TDF-FTC n=1003 participants at risk TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet	Oral Placebo n=1009 participants at risk TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel n=1007 participants at risk Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo n=1003 participants at risk Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Congenital, familial and genetic disorders Congenital anomaly in offspring	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.30% 3/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Eye disorders Retinal detachment	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Eye disorders Keratoconus	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Abdominal pain	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Gastric ulcer	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Gastritis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Vomiting	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
General disorders Death	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
General disorders Suprapubic pain	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Hepatobiliary disorders Cholecystitis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Diarrhoea	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Gastrointestinal disorders Food poisoning	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Abdominal wall abscess	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Appendicitis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Bartholin's abscess	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Breast abscess	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Disseminated tuberculosis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Gastroenteritis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.30% 3/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Gingival abscess	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Malaria	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Meningitis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Meningitis bacterial	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Meningitis viral	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Pericarditis tuberculous	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Pneumonia	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Postoperative wound infection	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Pulmonary tuberculosis	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.30% 3/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Pyelonephritis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Respiratory tract infection	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Sinusitis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Skin infection	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Tonsillitis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Tuberculosis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Vulval abscess	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Wound sepsis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Ankle fracture	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Electric shock	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Foreign body	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Injury	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Internal injury	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Laceration	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Lower limb fracture	0.20% 2/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Overdose	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Stab wound	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Thermal burn	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Injury, poisoning and procedural complications Upper limb fracture	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Investigations Alanine aminotransferase increased	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Investigations Aspartate aminotransferase increased	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gliomatosis cerebri	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Cerebral infarction	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Cerebrovascular accident	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Epilepsy	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Headache	0.20% 2/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.40% 4/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Loss of consciousness	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Meningism	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Migraine	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Optic neuritis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Syncope	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Transient ischaemic attack	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.20% 2/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.40% 4/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.40% 4/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.30% 3/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Intrapartum haemorrhage	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Post abortion haemorrhage	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.40% 4/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.50% 5/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Pregnancy, puerperium and perinatal conditions Retained products of conception	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Psychiatric disorders Bipolar disorder	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Psychiatric disorders Depression	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Psychiatric disorders Depression suicidal	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Psychiatric disorders Intentional self-injury	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Psychiatric disorders Suicidal ideation	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Psychiatric disorders Suicide attempt	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Breast discharge	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Breast enlargement	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Menorrhagia	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Pelvic pain	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.20% 2/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Vascular disorders Deep vein thrombosis	0.10% 1/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Vascular disorders Hypertension	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.10% 1/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	0.00% 0/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.

Other adverse events

Measure	Oral TDF n=1007 participants at risk TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet	Oral TDF-FTC n=1003 participants at risk TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet	Oral Placebo n=1009 participants at risk TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet	TFV Gel n=1007 participants at risk Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel	Gel Placebo n=1003 participants at risk Application of tenofovir placebo gel once daily Tenofovir placebo: placebo gel
Infections and infestations Genitourinary chlamydia infection	10.4% 105/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	14.4% 144/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	15.3% 154/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	9.9% 100/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	10.7% 107/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Genitourinary tract gonococcal infection	2.6% 26/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.6% 46/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.5% 45/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.0% 40/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.2% 32/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Urinary tract infection	2.6% 26/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.0% 40/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.3% 43/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.8% 28/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.6% 36/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Vaginitis bacterial	3.1% 31/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.1% 41/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.1% 41/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.2% 32/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.3% 43/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Vulvovaginal candidiasis	4.3% 43/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.8% 58/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.4% 54/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.9% 59/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.1% 51/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Infections and infestations Vulvovaginitis trichomonal	6.2% 62/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	6.5% 65/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	6.5% 66/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.6% 46/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.5% 55/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Investigations Alanine aminotransferase increased	8.9% 90/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	9.9% 99/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	11.5% 116/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	8.9% 90/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	8.4% 84/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Investigations Aspartate aminotransferase increased	6.9% 69/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	8.7% 87/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	8.7% 88/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	7.2% 73/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.8% 58/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Investigations Blood phosphorus decreased	2.9% 29/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.6% 26/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.4% 34/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.0% 40/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.9% 29/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Investigations Haemoglobin decreased	2.0% 20/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.8% 38/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.4% 44/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.7% 27/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.9% 29/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Metabolism and nutrition disorders Hypophosphataemia	17.0% 171/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	17.9% 180/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	18.2% 184/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	18.7% 188/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	16.8% 169/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Nervous system disorders Headache	3.2% 32/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.9% 39/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.4% 44/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.3% 23/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.0% 30/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Renal and urinary disorders Dysuria	14.2% 143/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	15.9% 159/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	17.4% 176/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	16.9% 170/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	18.7% 188/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Renal and urinary disorders Pollakiuria	1.6% 16/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.9% 39/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.1% 41/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.0% 30/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.4% 34/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Renal and urinary disorders Proteinuria	15.3% 154/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	20.2% 203/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	17.8% 180/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	16.4% 165/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	18.2% 183/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Cervical dysplasia	3.4% 34/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	10.0% 100/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	8.9% 90/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.8% 48/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.9% 49/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Menorrhagia	1.6% 16/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.1% 21/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.9% 29/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	3.3% 33/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	2.6% 26/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Metrorrhagia	2.9% 29/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.5% 55/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.0% 50/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.8% 48/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.1% 51/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Pelvic pain	3.1% 31/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	4.6% 46/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.2% 52/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.6% 56/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	5.2% 52/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Vaginal discharge	9.9% 100/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	12.9% 129/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	12.3% 124/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	11.8% 119/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	12.2% 122/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.
Reproductive system and breast disorders Vulvovaginal pruritus	5.6% 56/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	7.5% 75/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	7.9% 80/1009 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	14.9% 150/1007 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.	12.6% 126/1003 • each participant followed on study up to 2 years, 6 months Participants systematically reported any adverse experiences at monthly follow-up visits.

Additional Information

Jeanne Marrazzo, MD, MPH, FACP, FIDSA

University of Washington

Phone: 206-744-3679

Email: jmm2@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place