Trial Outcomes & Findings for Sustainable East Africa Research in Community Health (NCT NCT01864603)

NCT ID: NCT01864603

Last Updated: 2022-03-02

Results Overview

Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150395 participants
• Primary outcome timeframe: 3 years follow up
• Results posted on: 2022-03-02

Participant Flow

32 communities were enrolled and randomized to the intervention and control (16 per arm in each stage). We enrolled 150,395 community residents aged 15+ years at study baseline in Stage 1. At the start of Stage 2, 184,091 community residents (including in-migrants) aged 15+ years were enrolled. The analytic population for each endpoint is detailed in the Outcomes section.

Unit of analysis: Communites

Participant milestones

Measure	Intervention Intervention arm first stage: annual universal community-based HIV and multi-disease testing; ART for all HIV+; ART delivery using streamlined patient-centered care Intervention arm second stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP	Control Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care Active Comparator arm second stage
Stage 1 STARTED	79818 16	70577 16
Stage 1 COMPLETED	71028 16	62912 16
Stage 1 NOT COMPLETED	8790 0	7665 0
Stage 2 STARTED	91533 16	92558 16
Stage 2 COMPLETED	5477 16	0 0
Stage 2 NOT COMPLETED	86056 0	92558 16

Reasons for withdrawal

Measure	Intervention Intervention arm first stage: annual universal community-based HIV and multi-disease testing; ART for all HIV+; ART delivery using streamlined patient-centered care Intervention arm second stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP	Control Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care Active Comparator arm second stage
Stage 2 DSMB design modification	86056	92558

Baseline Characteristics

Marital status not reported by all participants

Baseline characteristics by cohort

Measure	Intervention n=79818 Participants Intervention arm first stage: Annual universal community- based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=70577 Participants Active Comparator arm first stage: Baseline universal community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care	Total n=150395 Participants Total of all reporting groups
Age, Customized 15-20 years	20053 Participants n=79818 Participants	16602 Participants n=70577 Participants	36655 Participants n=150395 Participants
Age, Customized 21-49 years	44047 Participants n=79818 Participants	39975 Participants n=70577 Participants	84022 Participants n=150395 Participants
Age, Customized >=50 years	15718 Participants n=79818 Participants	14000 Participants n=70577 Participants	29718 Participants n=150395 Participants
Sex: Female, Male Female	43770 Participants n=79818 Participants	38644 Participants n=70577 Participants	82414 Participants n=150395 Participants
Sex: Female, Male Male	36048 Participants n=79818 Participants	31933 Participants n=70577 Participants	67981 Participants n=150395 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=79818 Participants	0 Participants n=70577 Participants	0 Participants n=150395 Participants
Race (NIH/OMB) Asian	0 Participants n=79818 Participants	0 Participants n=70577 Participants	0 Participants n=150395 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=79818 Participants	0 Participants n=70577 Participants	0 Participants n=150395 Participants
Race (NIH/OMB) Black or African American	79818 Participants n=79818 Participants	70577 Participants n=70577 Participants	150395 Participants n=150395 Participants
Race (NIH/OMB) White	0 Participants n=79818 Participants	0 Participants n=70577 Participants	0 Participants n=150395 Participants
Race (NIH/OMB) More than one race	0 Participants n=79818 Participants	0 Participants n=70577 Participants	0 Participants n=150395 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=79818 Participants	0 Participants n=70577 Participants	0 Participants n=150395 Participants
Marital Status Single	23692 Participants n=79604 Participants • Marital status not reported by all participants	19392 Participants n=70436 Participants • Marital status not reported by all participants	43084 Participants n=150040 Participants • Marital status not reported by all participants
Marital Status Married	46684 Participants n=79604 Participants • Marital status not reported by all participants	42502 Participants n=70436 Participants • Marital status not reported by all participants	89186 Participants n=150040 Participants • Marital status not reported by all participants
Marital Status Widowed, divorced or separated	9228 Participants n=79604 Participants • Marital status not reported by all participants	8542 Participants n=70436 Participants • Marital status not reported by all participants	17770 Participants n=150040 Participants • Marital status not reported by all participants
Marital status - polygamous marriage	9575 Participants n=79595 Participants • Polygamous marriage status was not reported by all participants	9210 Participants n=70429 Participants • Polygamous marriage status was not reported by all participants	18785 Participants n=150024 Participants • Polygamous marriage status was not reported by all participants
Education Below primary school	50912 Participants n=79656 Participants • Education was not reported by all participants	45691 Participants n=70404 Participants • Education was not reported by all participants	96603 Participants n=150060 Participants • Education was not reported by all participants
Education Completed primary school	11478 Participants n=79656 Participants • Education was not reported by all participants	10305 Participants n=70404 Participants • Education was not reported by all participants	21783 Participants n=150060 Participants • Education was not reported by all participants
Education Any secondary school or higher	17266 Participants n=79656 Participants • Education was not reported by all participants	14408 Participants n=70404 Participants • Education was not reported by all participants	31674 Participants n=150060 Participants • Education was not reported by all participants
Occupation Formal sector	19753 Participants n=79597 Participants • Occupation not reported by all participants	15733 Participants n=70434 Participants • Occupation not reported by all participants	35486 Participants n=150031 Participants • Occupation not reported by all participants
Occupation High-risk informal sector	3235 Participants n=79597 Participants • Occupation not reported by all participants	4944 Participants n=70434 Participants • Occupation not reported by all participants	8179 Participants n=150031 Participants • Occupation not reported by all participants
Occupation Low-risk informal sector	48753 Participants n=79597 Participants • Occupation not reported by all participants	42341 Participants n=70434 Participants • Occupation not reported by all participants	91094 Participants n=150031 Participants • Occupation not reported by all participants
Occupation Other	3595 Participants n=79597 Participants • Occupation not reported by all participants	3201 Participants n=70434 Participants • Occupation not reported by all participants	6796 Participants n=150031 Participants • Occupation not reported by all participants
Occupation No job or disabled	4261 Participants n=79597 Participants • Occupation not reported by all participants	4215 Participants n=70434 Participants • Occupation not reported by all participants	8476 Participants n=150031 Participants • Occupation not reported by all participants
Household wealth index quintile First, indicating least wealth	12078 Participants n=79619 Participants • Household wealth survey data was not collected on all households.	11876 Participants n=70280 Participants • Household wealth survey data was not collected on all households.	23954 Participants n=149899 Participants • Household wealth survey data was not collected on all households.
Household wealth index quintile Second	13474 Participants n=79619 Participants • Household wealth survey data was not collected on all households.	12652 Participants n=70280 Participants • Household wealth survey data was not collected on all households.	26126 Participants n=149899 Participants • Household wealth survey data was not collected on all households.
Household wealth index quintile Third	15448 Participants n=79619 Participants • Household wealth survey data was not collected on all households.	14371 Participants n=70280 Participants • Household wealth survey data was not collected on all households.	29819 Participants n=149899 Participants • Household wealth survey data was not collected on all households.
Household wealth index quintile Fourth	17384 Participants n=79619 Participants • Household wealth survey data was not collected on all households.	15703 Participants n=70280 Participants • Household wealth survey data was not collected on all households.	33087 Participants n=149899 Participants • Household wealth survey data was not collected on all households.
Household wealth index quintile Fifth, indicating most wealth	21235 Participants n=79619 Participants • Household wealth survey data was not collected on all households.	15678 Participants n=70280 Participants • Household wealth survey data was not collected on all households.	36913 Participants n=149899 Participants • Household wealth survey data was not collected on all households.
Stable residents	76111 Participants n=79816 Participants • Two participants did not have data recorded to determine as stable resident.	67759 Participants n=70577 Participants • Two participants did not have data recorded to determine as stable resident.	143870 Participants n=150393 Participants • Two participants did not have data recorded to determine as stable resident.
Residents living with HIV	7212 Participants n=71605 Participants • HIV status was not available for all participants	6317 Participants n=63879 Participants • HIV status was not available for all participants	13529 Participants n=135484 Participants • HIV status was not available for all participants
Residents with prevalent hypertension	5953 Participants n=28877 Participants • Adults 30 years of age or older were included in the analysis.	5911 Participants n=26884 Participants • Adults 30 years of age or older were included in the analysis.	11864 Participants n=55761 Participants • Adults 30 years of age or older were included in the analysis.

PRIMARY outcome

Timeframe: 3 years follow up

Population: Baseline HIV- stable adult (15+years) residents

Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention.

Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Cumulative HIV Incidence	0.77 cumulative events per 100 persons Interval 0.6 to 0.93	0.81 cumulative events per 100 persons Interval 0.68 to 0.94

PRIMARY outcome

Timeframe: 3 years follow up

Population: Intervention population consists of persons aged 15+ years who initiated PrEP in Phase II intervention communities. The comparator population consists of propensity score matched historical controls from Phase I intervention communities. HIV testing was not comprehensively conducted during Phase 2.

HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I).

Outcome measures

Measure	Intervention n=5477 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=2061 Participants Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
HIV Incidence	0.35 Incident HIV per 100 person-year Interval 0.22 to 0.49	0.92 Incident HIV per 100 person-year Interval 0.49 to 1.41

SECONDARY outcome

Timeframe: 3 years follow up

Population: Adults without active TB and with HIV at baseline

Cumulative incidence of TB or death due to illness among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Incident TB Associated With HIV	3.7 cumulative events per 100 persons Interval 3.2 to 4.1	4.6 cumulative events per 100 persons Interval 4.1 to 5.2

SECONDARY outcome

Timeframe: 3 years follow up

Population: Known HIV+ at baseline

Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Overall Mortality	3.0 cumulative events per 100 persons Interval 2.6 to 3.4	3.9 cumulative events per 100 persons Interval 3.4 to 4.4

SECONDARY outcome

Timeframe: 3 years follow up

Population: Infants born in study period to women with HIV

Probability of an infant born to an HIV+ mother remaining alive and HIV uninfected.

Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
HIV-free Infant Survival	96.7 cumulative events per 100 persons Interval 94.4 to 99.0	93.6 cumulative events per 100 persons Interval 92.0 to 95.3

SECONDARY outcome

Timeframe: 3 years follow up

Population: HIV+ adults at year 3, including those out of care or without a prior HIV diagnosis

Percent of HIV+ adults with HIV RNA <=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Percent of HIV+ Adults With HIV RNA <=500 c/mL	79 cumulative events per 100 persons Interval 77.0 to 81.0	68 cumulative events per 100 persons Interval 66.0 to 70.0

SECONDARY outcome

Timeframe: 3 years follow up

Population: HIV+ adults linked to care with baseline HIV RNA \>=500 c/mL

Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia

Outcome measures

Measure	Intervention n=330 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=238 Participants Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Time in Care for HIV+ Adults With Baseline Viremia	81 percentage of days Interval 79.0 to 83.0	73 percentage of days Interval 68.0 to 79.0

SECONDARY outcome

Timeframe: 3 years follow up

Population: Baseline HIV+ without previous or current ART

Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Cumulative Incidence of ART-initiation	83 cumulative events per 100 persons Interval 80.0 to 85.0	50 cumulative events per 100 persons Interval 46.0 to 54.0

SECONDARY outcome

Timeframe: 3 years follow up

Population: Hypertensive adults (aged 30+) at year 3

hypertension control (greater than or equal to 140 mg Hg systolic or 90 mg Hg diastolic after 3 repeated readings) at year 3 among adults aged >= 30 years with hypertension.

Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=11664 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Hypertension Control	47 cumulative events per 100 persons Interval 45.0 to 49.0	37 cumulative events per 100 persons Interval 35.0 to 40.0

SECONDARY outcome

Timeframe: 3 years follow up

Population: Persons who initiated PrEP eligible for a follow-up visit. No data were collected for the second stage in the control arm due to DSMB approved design modification.

Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)

Outcome measures

Measure	Intervention n=5398 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Adherence to PrEP Treatment	3282 Participants	—

SECONDARY outcome

Timeframe: 3 years follow up

Population: Subsample of baseline HIV+ working-age adults (18-65)

HIV+ adults with on- and off-farm employment

Outcome measures

Measure	Intervention n=1425 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=1443 Participants Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Average Adults' on- and Off-farm Employment	85.5 cumulative events per 100 persons Interval 83.1 to 88.0	82.4 cumulative events per 100 persons Interval 80.0 to 84.9

SECONDARY outcome

Timeframe: 3 years follow up

Population: HIV+ ART experienced adults linked to care with baseline HIV RNA \>=500 c/mL

Plasma HIV RNA <400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Year 3 Viremia Among ART-experienced Persons With Baseline Viremia	67 cumulative events per 100 persons Interval 59.0 to 74.0	47 cumulative events per 100 persons Interval 36.0 to 58.0

SECONDARY outcome

Timeframe: 30 days after HIV test

Population: Persons testing HIV+ and not in care

Proportion of Persons Attending an HIV Clinic Visit by 30 Days After HIV Test Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Outcome measures

Measure	Intervention n=16 Communities Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=16 Communities Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Linkage to Care	41 cumulative events per 100 persons Interval 29.0 to 53.0	24 cumulative events per 100 persons Interval 13.0 to 35.0

SECONDARY outcome

Timeframe: 3 years follow up

Population: HIV-negative adults in stage 1 intervention arm who had repeat HIV testing

HIV incidence rates during the first and third year of follow up; Results from the Control arm are not provided because annual HIV incidence was not measured in the control arm (annual HIV testing was only conducted in the intervention arm).

Outcome measures

Measure	Intervention n=52474 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=58145 Participants Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
HIV Incidence Rate	0.43 per 100 person-years Interval 0.38 to 0.49	0.31 per 100 person-years Interval 0.26 to 0.36

SECONDARY outcome

Timeframe: Baseline

Population: ART naive HIV+ persons at baseline

HIV NNRTI drug-resistance mutations found at baseline

Outcome measures

Measure	Intervention n=74 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=107 Participants Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Prevalence of Transmitted HIV Drug-resistance Mutations	8 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 years follow up

Population: participants (age \>=18) who had a home visit during follow up year 3

Percentage of participants with chronic kidney disease (CKD)

Outcome measures

Measure	Intervention n=2100 Participants Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=1505 Participants Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Prevalence of Chronic Kidney Disease (CKD)	361 Participants	248 Participants

SECONDARY outcome

Timeframe: Follow up year 3

Population: Units are Intervention clinics using streamlined care; participants are HIV+ with at least one streamlined care visit

Cost of ART streamlined care delivery amount HIV+ persons

Outcome measures

Measure	Intervention n=17 Clinics Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care	Control n=17 Clinics Baseline community-based HIV and multi-disease testing; ART eligibility and delivery by country standard of care
Total Costs of Programming (ART)	291 USD per person year Interval 279.0 to 303.0	221 USD per person year Interval 196.0 to 246.0

Adverse Events

Intervention Arm Stage 1

Serious events: 89 serious events

Other events: 80 other events

Deaths: 1217 deaths

Intervention Arm Stage II

Serious events: 50 serious events

Other events: 17 other events

Deaths: 18 deaths

Serious adverse events

Measure	Intervention Arm Stage 1 n=1671 participants at risk Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care Adverse events monitored among persons initiating ART outside of National guidelines	Intervention Arm Stage II n=5447 participants at risk Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP Adverse events monitored among persons initiating PrEP
Gastrointestinal disorders Abdominal Pain	0.24% 4/1671 • Number of events 4 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Psychiatric disorders Altered Mental Status	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Anemia	0.78% 13/1671 • Number of events 14 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.06% 3/5447 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Gastrointestinal disorders Ascites	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Cardiac disorders Chest Pain	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Respiratory, thoracic and mediastinal disorders Cough	0.18% 3/1671 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Skin and subcutaneous tissue disorders Cutaneous Eruption	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Deep Vein Thrombosis	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Dehydration	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Diarrhea	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated ALT	0.24% 4/1671 • Number of events 4 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated AST	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated Creatinine	0.24% 4/1671 • Number of events 4 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Fatigue	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Musculoskeletal and connective tissue disorders Fracture	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.04% 2/5447 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Infections and infestations Genital Ulcer	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Hemoptysis	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Hemorrhage	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Incontinence	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Intoxication	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Nervous system disorders Neuromuscular weakness	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Neutropenia	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Pain	0.36% 6/1671 • Number of events 7 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Pre-term Labor	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Nervous system disorders Seizure	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Musculoskeletal and connective tissue disorders Soft Tissue Injury	0.18% 3/1671 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Spontaneous Abortion	0.36% 6/1671 • Number of events 6 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.06% 3/5447 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Temperature	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Metabolism and nutrition disorders Unintentional Weight Loss	0.18% 3/1671 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Urticaria	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders UTI	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Vomiting	0.18% 3/1671 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Respiratory, thoracic and mediastinal disorders Wheezing	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Wound	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Fetal Demise	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Fever	0.48% 8/1671 • Number of events 8 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Blood clot in brain	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Cesarean Infant Delivery	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Nervous system disorders Head Injury	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Reproductive system and breast disorders Uterine Fibroids	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Musculoskeletal and connective tissue disorders Injury	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Respiratory, thoracic and mediastinal disorders Pulmonary Tuberculosis	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.04% 2/5447 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Ruptured Ectopic Pregnancy	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Infections and infestations Sepsis	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Infections and infestations Seroconversion	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.46% 25/5447 • Number of events 25 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Reproductive system and breast disorders Uterine Prolapse	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Infections and infestations Typhoid	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.

Other adverse events

Measure	Intervention Arm Stage 1 n=1671 participants at risk Annual universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care Adverse events monitored among persons initiating ART outside of National guidelines	Intervention Arm Stage II n=5447 participants at risk Baseline universal community-based HIV and multi-disease testing; ART eligibility for all HIV+; ART delivery using streamlined patient-centered care; targeted population-level PrEP Adverse events monitored among persons initiating PrEP
Gastrointestinal disorders Abdominal Pain	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Psychiatric disorders Altered Mental Status	0.24% 4/1671 • Number of events 4 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Anemia	1.1% 18/1671 • Number of events 18 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Dehydration	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Ear and labyrinth disorders Dizziness	0.18% 3/1671 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Eye disorders Eye Discharge	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated ALT	0.66% 11/1671 • Number of events 11 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated AST	0.36% 6/1671 • Number of events 6 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated Creatinine	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Fatigue	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Fever	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Reproductive system and breast disorders Gynaecomastia	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Hyperglycemia	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Hyperkalemia	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Hyponatraemia	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Blood and lymphatic system disorders Leucopenia	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Neutropenia	0.66% 11/1671 • Number of events 11 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Pain	0.36% 6/1671 • Number of events 6 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Skin and subcutaneous tissue disorders Rash	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Nervous system disorders Seizure	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Spontaneous Abortion	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.04% 2/5447 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Thrombocytopenia	0.24% 4/1671 • Number of events 4 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Metabolism and nutrition disorders Unintentional Weight Loss	0.06% 1/1671 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
General disorders Vomiting	0.12% 2/1671 • Number of events 2 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.00% 0/5447 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Renal and urinary disorders Elevated Bilirubin	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Reproductive system and breast disorders Uterine Bleeding	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.07% 4/5447 • Number of events 4 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Nervous system disorders Dizzinesss	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.06% 3/5447 • Number of events 3 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.
Nervous system disorders Headache	0.00% 0/1671 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.	0.02% 1/5447 • Number of events 1 • Phase I: 3 years Phase II: 3 years This was a community randomized community-based trial. In accordance with our approved data safety monitoring plan, adverse events were monitored and assessed in a different population of patients than all cause mortality. Adverse events were only monitored for participants who received any biomedical treatment or prevention intervention outside of current country standard of care.

Additional Information

Tamara Clark

University of California, San Francisco

Phone: 628-206-8790

Email: Tamara.Clark@ucsf.edu

Results disclosure agreements

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