Trial Outcomes & Findings for SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (NCT NCT04810650)

Last Updated: 2025-02-06

Results Overview

Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report.

Recruitment status

COMPLETED

Study phase

Target enrollment

2233 participants

Primary outcome timeframe

48 weeks

Results posted on

2025-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control Standard of Care: Local country standard of care protocols	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Antenatal Clinics Control Standard of Care: Local country standard of care protocols	PREP/PEP at Community Households Dynamic Prevention Intervention PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Community Households Control Standard of Care: Local country standard of care protocols	Mobility Dynamic Treatment Intervention Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel	Mobility Control Standard of Care: Local country standard of care protocols	Healthy Living for Heavy Alcohol Users Intervention Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls	Heavy Alcohol Users Control Standard of Care: Local country standard of care protocols	Hypertension Linkage Intervention Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits	Hypertension Linkage Control Standard of Care: Local country standard of care protocols	Hypertension Community Intervention Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications	Hypertension Community Control Standard of Care: Local country standard of care protocols
Overall Study STARTED	197	206	203	197	212	217	102	99	198	203	100	99	98	102
Overall Study COMPLETED	182	194	196	188	202	211	100	96	185	192	97	99	93	92
Overall Study NOT COMPLETED	15	12	7	9	10	6	2	3	13	11	3	0	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control Standard of Care: Local country standard of care protocols	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Antenatal Clinics Control Standard of Care: Local country standard of care protocols	PREP/PEP at Community Households Dynamic Prevention Intervention PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Community Households Control Standard of Care: Local country standard of care protocols	Mobility Dynamic Treatment Intervention Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel	Mobility Control Standard of Care: Local country standard of care protocols	Healthy Living for Heavy Alcohol Users Intervention Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls	Heavy Alcohol Users Control Standard of Care: Local country standard of care protocols	Hypertension Linkage Intervention Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits	Hypertension Community Intervention Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications	Hypertension Community Control Standard of Care: Local country standard of care protocols
Overall Study Disenrolled in error	0	0	0	0	0	0	0	0	1	0	0	0	0
Overall Study Death	0	0	0	0	0	0	2	2	0	1	0	2	1
Overall Study Moved/transferred care	0	0	0	0	0	0	0	1	12	10	0	0	0
Overall Study Lost to Follow-up	15	12	7	9	10	6	0	0	0	0	1	3	9
Overall Study Participant declined	0	0	0	0	0	0	0	0	0	0	2	0	0

Baseline Characteristics

1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=197 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=206 Participants Standard of Care: Local country standard of care protocols	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention n=203 Participants PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Antenatal Clinics Control n=197 Participants Standard of Care: Local country standard of care protocols	PREP/PEP at Community Households Dynamic Prevention Intervention n=212 Participants PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Community Households Control n=217 Participants Standard of Care: Local country standard of care protocols	Mobility Dynamic Treatment Intervention n=102 Participants Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel	Mobility Control n=99 Participants Standard of Care: Local country standard of care protocols	Healthy Living for Heavy Alcohol Users Intervention n=197 Participants Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls	Heavy Alcohol Users Control n=203 Participants Standard of Care: Local country standard of care protocols	Hypertension Linkage Intervention n=100 Participants Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits	Hypertension Linkage Control n=99 Participants Standard of Care: Local country standard of care protocols	Hypertension Community Intervention n=98 Participants Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications	Hypertension Community Control n=102 Participants Standard of Care: Local country standard of care protocols	Total n=2232 Participants Total of all reporting groups
Age, Continuous	27 years n=5 Participants	29 years n=7 Participants	24 years n=5 Participants	24 years n=4 Participants	29 years n=21 Participants	30 years n=8 Participants	38 years n=8 Participants	36 years n=24 Participants	37 years n=42 Participants	37 years n=42 Participants	57 years n=42 Participants	56 years n=42 Participants	60 years n=36 Participants	63 years n=36 Participants	34 years n=24 Participants
Sex: Female, Male Female	120 Participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	125 Participants n=7 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	203 Participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	197 Participants n=4 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	124 Participants n=21 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	119 Participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	56 Participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	53 Participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	60 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	71 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	60 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	59 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	69 Participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	70 Participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	1386 Participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.
Sex: Female, Male Male	77 Participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	81 Participants n=7 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	0 Participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	0 Participants n=4 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	88 Participants n=21 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	98 Participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	46 Participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	46 Participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	137 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	132 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	40 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	40 Participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	29 Participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	32 Participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	846 Participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.
Race/Ethnicity, Customized African	197 Participants n=5 Participants	206 Participants n=7 Participants	203 Participants n=5 Participants	197 Participants n=4 Participants	212 Participants n=21 Participants	217 Participants n=8 Participants	102 Participants n=8 Participants	99 Participants n=24 Participants	197 Participants n=42 Participants	203 Participants n=42 Participants	100 Participants n=42 Participants	99 Participants n=42 Participants	98 Participants n=36 Participants	102 Participants n=36 Participants	2232 Participants n=24 Participants
Region of Enrollment Uganda	100 participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	102 participants n=7 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	100 participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	99 participants n=4 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	102 participants n=21 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	117 participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	51 participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	49 participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	113 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	117 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	50 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	50 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	48 participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	52 participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	1150 participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.
Region of Enrollment Kenya	97 participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	104 participants n=7 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	103 participants n=5 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	98 participants n=4 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	110 participants n=21 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	100 participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	51 participants n=8 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	50 participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	84 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	86 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	50 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	49 participants n=42 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	50 participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	50 participants n=36 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.	1082 participants n=24 Participants • 1 participant enrolled in the Heavy Alcohol Use primary outcome's intervention arm was not analyzed because the individual was disenrolled in error.

PRIMARY outcome

Timeframe: 48 weeks

Population: Participants who completed the Week 48 visit.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=182 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=194 Participants Standard of Care: Local country standard of care protocols
Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP	47.5 Percentage of months Interval 42.3 to 52.7	18.3 Percentage of months Interval 14.4 to 22.1

PRIMARY outcome

Timeframe: 48 weeks

Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=196 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=188 Participants Standard of Care: Local country standard of care protocols
Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP	70 Percentage of months Interval 65.0 to 74.0	29 Percentage of months Interval 25.0 to 34.0

PRIMARY outcome

Timeframe: 48 weeks

Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=202 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=211 Participants Standard of Care: Local country standard of care protocols
Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP	28.0 Percentage of months Interval 23.5 to 32.4	0.5 Percentage of months Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 48 weeks

Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=100 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=96 Participants Standard of Care: Local country standard of care protocols
Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml	85 Participants	83 Participants

PRIMARY outcome

Timeframe: 24 weeks

Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=185 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=192 Participants Standard of Care: Local country standard of care protocols
Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml	83 Percentage of participants with VL <400 Interval 78.0 to 89.0	82 Percentage of participants with VL <400 Interval 77.0 to 87.0

PRIMARY outcome

Timeframe: 30 days

Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=100 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=99 Participants Standard of Care: Local country standard of care protocols
Number of Participants Who Linked to Hypertension Care	96 Participants	65 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Participants who completed the 24-week follow-up visit

Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures \<140 mmHg systolic and \<90 mmHg diastolic.

Outcome measures

Outcome measures
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=96 Participants PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=99 Participants Standard of Care: Local country standard of care protocols
Percentage of Participants With Hypertension Control <140/90 mmHg	77 Percentage of persons with HTN control Interval 69.0 to 85.0	51 Percentage of persons with HTN control Interval 42.0 to 60.0

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention n=197 participants at risk PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Outpatient Clinics Control n=206 participants at risk Standard of Care: Local country standard of care protocols	PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention n=203 participants at risk PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Antenatal Clinics Control n=197 participants at risk Standard of Care: Local country standard of care protocols	PREP/PEP at Community Households Dynamic Prevention Intervention n=212 participants at risk PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services	PREP/PEP at Community Households Control n=217 participants at risk Standard of Care: Local country standard of care protocols	Mobility Dynamic Treatment Intervention n=102 participants at risk Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel	Mobility Control n=99 participants at risk Standard of Care: Local country standard of care protocols	Healthy Living for Heavy Alcohol Users Intervention n=197 participants at risk Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls	Heavy Alcohol Users Control n=203 participants at risk Standard of Care: Local country standard of care protocols	Hypertension Linkage Intervention n=100 participants at risk Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits	Hypertension Linkage Control n=99 participants at risk Standard of Care: Local country standard of care protocols	Hypertension Community Intervention n=98 participants at risk Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications	Hypertension Community Control n=102 participants at risk Standard of Care: Local country standard of care protocols
Pregnancy, puerperium and perinatal conditions Death of premature infant	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.5% 3/203 • Number of events 3 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Pregnancy, puerperium and perinatal conditions Emergency caesarian section	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	2.0% 4/203 • Number of events 4 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.49% 1/203 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Pregnancy, puerperium and perinatal conditions Miscarriage	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	2.5% 5/203 • Number of events 5 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 2/197 • Number of events 2 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Social circumstances Intimate partner violence	1.0% 2/197 • Number of events 2 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.5% 3/203 • Number of events 3 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.94% 2/212 • Number of events 2 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Pregnancy, puerperium and perinatal conditions Pre-term delivery	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.49% 1/203 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Injury, poisoning and procedural complications Injury	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/100 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Endocrine disorders Diabetes Type 2	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Reproductive system and breast disorders Uterine fibroids	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Psychiatric disorders Suicidal ideation	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
General disorders Death due to unknown illness	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/98 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.98% 1/102 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Pregnancy, puerperium and perinatal conditions Hydatidiform mole	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.47% 1/212 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Musculoskeletal and connective tissue disorders Lumbar spondylosis	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.46% 1/217 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Pregnancy, puerperium and perinatal conditions Incomplete abortion	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.47% 1/212 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Infections and infestations Cryptococcal meningitis	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/99 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Infections and infestations Pulmonary tuberculosis	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.98% 1/102 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.49% 1/203 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/100 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Social circumstances Homicide	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	2.0% 2/102 • Number of events 2 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/99 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Renal and urinary disorders Urine retention	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.51% 1/197 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Cardiac disorders Severe hypertension	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	2.0% 2/100 • Number of events 2 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/98 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Infections and infestations Pneumonia	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/100 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/98 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Renal and urinary disorders Chronic renal failure	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	2.0% 2/98 • Number of events 2 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.
Gastrointestinal disorders Right inguinal hernia	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/206 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/212 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/217 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/197 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/203 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/100 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/99 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	1.0% 1/98 • Number of events 1 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.	0.00% 0/102 • Between 30 days and 48 weeks depending on the primary outcome measure. Serious adverse events were reported regardless of relationship to the study intervention. Control arm participants were not contacted during the study except at baseline and at milestone visits. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in both intervention and control arms.

Other adverse events

Adverse event data not reported

Additional Information

Douglas Black

University of California, San Francisco

Phone: 4158063016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place