Trial Outcomes & Findings for Partnership for Research on Ebola VACcinations (NCT NCT02876328)

Last Updated: 2024-06-26

Results Overview

Antibody responder at 12 months is defined as a participant who experiences a 4-fold increase in antibody level from baseline and for whom the antibody level at 12 months is greater than or equal to 200 EU/mL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4789 participants

Primary outcome timeframe

Measured through Month 12

Results posted on

2024-06-26

Participant Flow

Healthy volunteers were enrolled at 6 sites in 4 countries: Guinea at 2 sites (Landreah and Maferinyah), Liberia (Redemption Hospital), Mali at 2 sites (Center for Vaccine Development and the University Clinical Research Center), and Sierra Leone (Mambolo). Total enrollment includes participants enrolled in all versions of the protocol, but only participants enrolled in version 4.0 of the protocol are included in the primary outcome analysis.

4789 participants were enrolled in the study, however, only 4786 participants are part of the data analysis.

Participant milestones

Participant milestones
Measure	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm	Placebo (1 mL) - Adults (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh	Title: Placebo (0.5 mL) - Children (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh	Placebo (1 mL) - Children (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm	Placebo (1 mL) - Adults (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (1 mL) - Children (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v2.0) Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v2.0) Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
Overall Study STARTED	396	221	395	197	191	403	179	407	202	210	187	99	177	99	100	227	107	237	108	107	324	172	34	7
Overall Study COMPLETED	379	208	378	188	181	388	175	395	192	202	182	98	172	95	96	223	102	227	106	105	312	164	33	7
Overall Study NOT COMPLETED	17	13	17	9	10	15	4	12	10	8	5	1	5	4	4	4	5	10	2	2	12	8	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm	Placebo (1 mL) - Adults (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh	Title: Placebo (0.5 mL) - Children (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh	Placebo (1 mL) - Children (v4.0) Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm	Placebo (1 mL) - Adults (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (1 mL) - Children (v3.0) Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v2.0) Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh
Overall Study Death	2	1	3	0	0	0	1	3	0	1	1	0	0	0	0	0	1	1	0	0	0	1	0
Overall Study Withdrawal by Subject	0	2	3	3	0	1	0	1	1	2	0	0	0	0	0	0	1	3	0	0	1	0	0
Overall Study Missed 12 Month Visit	15	10	11	6	10	14	3	8	9	5	4	1	5	4	4	4	3	6	2	2	11	7	1

Baseline Characteristics

Adults and children are analyzed separately.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) n=396 Participants Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v4.0) n=221 Participants Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) n=395 Participants Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) n=197 Participants Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm	Placebo (1 mL) - Adults (v4.0) n=191 Participants Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) n=403 Participants Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh	Placebo (0.5 mL) - Children (v4.0) n=179 Participants Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) n=407 Participants Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) n=202 Participants Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh	Placebo (1 mL) - Children (v4.0) n=210 Participants Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) n=187 Participants Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v3.0) n=99 Participants Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) n=177 Participants Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) n=99 Participants Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm	Placebo (1 mL) - Adults (v3.0) n=100 Participants Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) n=227 Participants Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v3.0) n=107 Participants Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) n=237 Participants Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) n=108 Participants Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (1 mL) - Children (v3.0) n=107 Participants Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) n=324 Participants Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v2.0) n=172 Participants Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) n=34 Participants Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v2.0) n=7 Participants Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	Total n=4786 Participants Total of all reporting groups
Age, Continuous Adults	27 years n=396 Participants • Adults and children are analyzed separately.	28 years n=221 Participants • Adults and children are analyzed separately.	27 years n=395 Participants • Adults and children are analyzed separately.	26 years n=197 Participants • Adults and children are analyzed separately.	26 years n=191 Participants • Adults and children are analyzed separately.	—	—	—	—	—	30 years n=187 Participants • Adults and children are analyzed separately.	31 years n=99 Participants • Adults and children are analyzed separately.	29 years n=177 Participants • Adults and children are analyzed separately.	28 years n=99 Participants • Adults and children are analyzed separately.	28 years n=100 Participants • Adults and children are analyzed separately.	—	—	—	—	—	27 years n=324 Participants • Adults and children are analyzed separately.	27 years n=172 Participants • Adults and children are analyzed separately.	—	—	27 years n=2558 Participants • Adults and children are analyzed separately.
Age, Continuous Children	—	—	—	—	—	8 years n=403 Participants • Adults and children are analyzed separately.	8 years n=179 Participants • Adults and children are analyzed separately.	9 years n=407 Participants • Adults and children are analyzed separately.	8 years n=202 Participants • Adults and children are analyzed separately.	8 years n=210 Participants • Adults and children are analyzed separately.	—	—	—	—	—	12 years n=227 Participants • Adults and children are analyzed separately.	12 years n=107 Participants • Adults and children are analyzed separately.	12 years n=237 Participants • Adults and children are analyzed separately.	12 years n=108 Participants • Adults and children are analyzed separately.	12 years n=107 Participants • Adults and children are analyzed separately.	—	—	14 years n=34 Participants • Adults and children are analyzed separately.	14 years n=7 Participants • Adults and children are analyzed separately.	10 years n=2228 Participants • Adults and children are analyzed separately.
Age, Customized 1-4 years	0 Participants n=396 Participants	0 Participants n=221 Participants	0 Participants n=395 Participants	0 Participants n=197 Participants	0 Participants n=191 Participants	137 Participants n=403 Participants	59 Participants n=179 Participants	123 Participants n=407 Participants	71 Participants n=202 Participants	77 Participants n=210 Participants	0 Participants n=187 Participants	0 Participants n=99 Participants	0 Participants n=177 Participants	0 Participants n=99 Participants	0 Participants n=100 Participants	25 Participants n=227 Participants	12 Participants n=107 Participants	24 Participants n=237 Participants	9 Participants n=108 Participants	12 Participants n=107 Participants	0 Participants n=324 Participants	0 Participants n=172 Participants	0 Participants n=34 Participants	0 Participants n=7 Participants	549 Participants n=4786 Participants
Age, Customized 5-11 years	0 Participants n=396 Participants	0 Participants n=221 Participants	0 Participants n=395 Participants	0 Participants n=197 Participants	0 Participants n=191 Participants	127 Participants n=403 Participants	59 Participants n=179 Participants	146 Participants n=407 Participants	65 Participants n=202 Participants	70 Participants n=210 Participants	0 Participants n=187 Participants	0 Participants n=99 Participants	0 Participants n=177 Participants	0 Participants n=99 Participants	0 Participants n=100 Participants	76 Participants n=227 Participants	37 Participants n=107 Participants	86 Participants n=237 Participants	43 Participants n=108 Participants	41 Participants n=107 Participants	0 Participants n=324 Participants	0 Participants n=172 Participants	0 Participants n=34 Participants	0 Participants n=7 Participants	750 Participants n=4786 Participants
Age, Customized 12-17 years	0 Participants n=396 Participants	0 Participants n=221 Participants	0 Participants n=395 Participants	0 Participants n=197 Participants	0 Participants n=191 Participants	139 Participants n=403 Participants	61 Participants n=179 Participants	138 Participants n=407 Participants	66 Participants n=202 Participants	63 Participants n=210 Participants	0 Participants n=187 Participants	0 Participants n=99 Participants	0 Participants n=177 Participants	0 Participants n=99 Participants	0 Participants n=100 Participants	126 Participants n=227 Participants	58 Participants n=107 Participants	127 Participants n=237 Participants	56 Participants n=108 Participants	54 Participants n=107 Participants	0 Participants n=324 Participants	0 Participants n=172 Participants	34 Participants n=34 Participants	7 Participants n=7 Participants	929 Participants n=4786 Participants
Age, Customized Adults >18 years	396 Participants n=396 Participants	221 Participants n=221 Participants	395 Participants n=395 Participants	197 Participants n=197 Participants	191 Participants n=191 Participants	0 Participants n=403 Participants	0 Participants n=179 Participants	0 Participants n=407 Participants	0 Participants n=202 Participants	0 Participants n=210 Participants	187 Participants n=187 Participants	99 Participants n=99 Participants	177 Participants n=177 Participants	99 Participants n=99 Participants	100 Participants n=100 Participants	0 Participants n=227 Participants	0 Participants n=107 Participants	0 Participants n=237 Participants	0 Participants n=108 Participants	0 Participants n=107 Participants	324 Participants n=324 Participants	172 Participants n=172 Participants	0 Participants n=34 Participants	0 Participants n=7 Participants	2558 Participants n=4786 Participants
Sex: Female, Male Adults · Female	171 Participants n=396 Participants • Adults and children are analyzed separately.	106 Participants n=221 Participants • Adults and children are analyzed separately.	182 Participants n=395 Participants • Adults and children are analyzed separately.	87 Participants n=197 Participants • Adults and children are analyzed separately.	81 Participants n=191 Participants • Adults and children are analyzed separately.	—	—	—	—	—	99 Participants n=187 Participants • Adults and children are analyzed separately.	45 Participants n=99 Participants • Adults and children are analyzed separately.	75 Participants n=177 Participants • Adults and children are analyzed separately.	43 Participants n=99 Participants • Adults and children are analyzed separately.	49 Participants n=100 Participants • Adults and children are analyzed separately.	—	—	—	—	—	120 Participants n=324 Participants • Adults and children are analyzed separately.	60 Participants n=172 Participants • Adults and children are analyzed separately.	—	—	1118 Participants n=2558 Participants • Adults and children are analyzed separately.
Sex: Female, Male Adults · Male	225 Participants n=396 Participants • Adults and children are analyzed separately.	115 Participants n=221 Participants • Adults and children are analyzed separately.	213 Participants n=395 Participants • Adults and children are analyzed separately.	110 Participants n=197 Participants • Adults and children are analyzed separately.	110 Participants n=191 Participants • Adults and children are analyzed separately.	—	—	—	—	—	88 Participants n=187 Participants • Adults and children are analyzed separately.	54 Participants n=99 Participants • Adults and children are analyzed separately.	102 Participants n=177 Participants • Adults and children are analyzed separately.	56 Participants n=99 Participants • Adults and children are analyzed separately.	51 Participants n=100 Participants • Adults and children are analyzed separately.	—	—	—	—	—	204 Participants n=324 Participants • Adults and children are analyzed separately.	112 Participants n=172 Participants • Adults and children are analyzed separately.	—	—	1440 Participants n=2558 Participants • Adults and children are analyzed separately.
Sex: Female, Male Children · Female	—	—	—	—	—	186 Participants n=403 Participants • Adults and children are analyzed separately.	87 Participants n=179 Participants • Adults and children are analyzed separately.	185 Participants n=407 Participants • Adults and children are analyzed separately.	85 Participants n=202 Participants • Adults and children are analyzed separately.	95 Participants n=210 Participants • Adults and children are analyzed separately.	—	—	—	—	—	122 Participants n=227 Participants • Adults and children are analyzed separately.	48 Participants n=107 Participants • Adults and children are analyzed separately.	117 Participants n=237 Participants • Adults and children are analyzed separately.	55 Participants n=108 Participants • Adults and children are analyzed separately.	53 Participants n=107 Participants • Adults and children are analyzed separately.	—	—	19 Participants n=34 Participants • Adults and children are analyzed separately.	5 Participants n=7 Participants • Adults and children are analyzed separately.	1057 Participants n=2228 Participants • Adults and children are analyzed separately.
Sex: Female, Male Children · Male	—	—	—	—	—	217 Participants n=403 Participants • Adults and children are analyzed separately.	92 Participants n=179 Participants • Adults and children are analyzed separately.	222 Participants n=407 Participants • Adults and children are analyzed separately.	117 Participants n=202 Participants • Adults and children are analyzed separately.	115 Participants n=210 Participants • Adults and children are analyzed separately.	—	—	—	—	—	105 Participants n=227 Participants • Adults and children are analyzed separately.	59 Participants n=107 Participants • Adults and children are analyzed separately.	120 Participants n=237 Participants • Adults and children are analyzed separately.	53 Participants n=108 Participants • Adults and children are analyzed separately.	54 Participants n=107 Participants • Adults and children are analyzed separately.	—	—	15 Participants n=34 Participants • Adults and children are analyzed separately.	2 Participants n=7 Participants • Adults and children are analyzed separately.	1171 Participants n=2228 Participants • Adults and children are analyzed separately.
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Guinea	121 Participants n=396 Participants • Adults and children are analyzed separately.	72 Participants n=221 Participants • Adults and children are analyzed separately.	130 Participants n=395 Participants • Adults and children are analyzed separately.	66 Participants n=197 Participants • Adults and children are analyzed separately.	63 Participants n=191 Participants • Adults and children are analyzed separately.	163 Participants n=403 Participants • Adults and children are analyzed separately.	71 Participants n=179 Participants • Adults and children are analyzed separately.	156 Participants n=407 Participants • Adults and children are analyzed separately.	77 Participants n=202 Participants • Adults and children are analyzed separately.	79 Participants n=210 Participants • Adults and children are analyzed separately.	144 Participants n=187 Participants • Adults and children are analyzed separately.	80 Participants n=99 Participants • Adults and children are analyzed separately.	141 Participants n=177 Participants • Adults and children are analyzed separately.	77 Participants n=99 Participants • Adults and children are analyzed separately.	76 Participants n=100 Participants • Adults and children are analyzed separately.	160 Participants n=227 Participants • Adults and children are analyzed separately.	72 Participants n=107 Participants • Adults and children are analyzed separately.	163 Participants n=237 Participants • Adults and children are analyzed separately.	76 Participants n=108 Participants • Adults and children are analyzed separately.	77 Participants n=107 Participants • Adults and children are analyzed separately.	158 Participants n=324 Participants • Adults and children are analyzed separately.	84 Participants n=172 Participants • Adults and children are analyzed separately.	17 Participants n=34 Participants • Adults and children are analyzed separately.	4 Participants n=7 Participants • Adults and children are analyzed separately.	1115 Participants n=2228 Participants • Adults and children are analyzed separately.
Region of Enrollment Liberia	73 Participants n=396 Participants • Adults and children are analyzed separately.	43 Participants n=221 Participants • Adults and children are analyzed separately.	70 Participants n=395 Participants • Adults and children are analyzed separately.	35 Participants n=197 Participants • Adults and children are analyzed separately.	38 Participants n=191 Participants • Adults and children are analyzed separately.	64 Participants n=403 Participants • Adults and children are analyzed separately.	25 Participants n=179 Participants • Adults and children are analyzed separately.	66 Participants n=407 Participants • Adults and children are analyzed separately.	33 Participants n=202 Participants • Adults and children are analyzed separately.	30 Participants n=210 Participants • Adults and children are analyzed separately.	43 Participants n=187 Participants • Adults and children are analyzed separately.	19 Participants n=99 Participants • Adults and children are analyzed separately.	36 Participants n=177 Participants • Adults and children are analyzed separately.	22 Participants n=99 Participants • Adults and children are analyzed separately.	24 Participants n=100 Participants • Adults and children are analyzed separately.	67 Participants n=227 Participants • Adults and children are analyzed separately.	35 Participants n=107 Participants • Adults and children are analyzed separately.	74 Participants n=237 Participants • Adults and children are analyzed separately.	32 Participants n=108 Participants • Adults and children are analyzed separately.	30 Participants n=107 Participants • Adults and children are analyzed separately.	166 Participants n=324 Participants • Adults and children are analyzed separately.	88 Participants n=172 Participants • Adults and children are analyzed separately.	17 Participants n=34 Participants • Adults and children are analyzed separately.	3 Participants n=7 Participants • Adults and children are analyzed separately.	476 Participants n=2228 Participants • Adults and children are analyzed separately.
Region of Enrollment Mali	81 Participants n=396 Participants • Adults and children are analyzed separately.	48 Participants n=221 Participants • Adults and children are analyzed separately.	84 Participants n=395 Participants • Adults and children are analyzed separately.	41 Participants n=197 Participants • Adults and children are analyzed separately.	38 Participants n=191 Participants • Adults and children are analyzed separately.	95 Participants n=403 Participants • Adults and children are analyzed separately.	40 Participants n=179 Participants • Adults and children are analyzed separately.	94 Participants n=407 Participants • Adults and children are analyzed separately.	46 Participants n=202 Participants • Adults and children are analyzed separately.	51 Participants n=210 Participants • Adults and children are analyzed separately.	0 Participants n=187 Participants • Adults and children are analyzed separately.	0 Participants n=99 Participants • Adults and children are analyzed separately.	0 Participants n=177 Participants • Adults and children are analyzed separately.	0 Participants n=99 Participants • Adults and children are analyzed separately.	0 Participants n=100 Participants • Adults and children are analyzed separately.	0 Participants n=227 Participants • Adults and children are analyzed separately.	0 Participants n=107 Participants • Adults and children are analyzed separately.	0 Participants n=237 Participants • Adults and children are analyzed separately.	0 Participants n=108 Participants • Adults and children are analyzed separately.	0 Participants n=107 Participants • Adults and children are analyzed separately.	0 Participants n=324 Participants • Adults and children are analyzed separately.	0 Participants n=172 Participants • Adults and children are analyzed separately.	0 Participants n=34 Participants • Adults and children are analyzed separately.	0 Participants n=7 Participants • Adults and children are analyzed separately.	326 Participants n=2228 Participants • Adults and children are analyzed separately.
Region of Enrollment Sierra Leone	121 Participants n=396 Participants • Adults and children are analyzed separately.	58 Participants n=221 Participants • Adults and children are analyzed separately.	111 Participants n=395 Participants • Adults and children are analyzed separately.	55 Participants n=197 Participants • Adults and children are analyzed separately.	52 Participants n=191 Participants • Adults and children are analyzed separately.	81 Participants n=403 Participants • Adults and children are analyzed separately.	43 Participants n=179 Participants • Adults and children are analyzed separately.	91 Participants n=407 Participants • Adults and children are analyzed separately.	46 Participants n=202 Participants • Adults and children are analyzed separately.	50 Participants n=210 Participants • Adults and children are analyzed separately.	0 Participants n=187 Participants • Adults and children are analyzed separately.	0 Participants n=99 Participants • Adults and children are analyzed separately.	0 Participants n=177 Participants • Adults and children are analyzed separately.	0 Participants n=99 Participants • Adults and children are analyzed separately.	0 Participants n=100 Participants • Adults and children are analyzed separately.	0 Participants n=227 Participants • Adults and children are analyzed separately.	0 Participants n=107 Participants • Adults and children are analyzed separately.	0 Participants n=237 Participants • Adults and children are analyzed separately.	0 Participants n=108 Participants • Adults and children are analyzed separately.	0 Participants n=107 Participants • Adults and children are analyzed separately.	0 Participants n=324 Participants • Adults and children are analyzed separately.	0 Participants n=172 Participants • Adults and children are analyzed separately.	0 Participants n=34 Participants • Adults and children are analyzed separately.	0 Participants n=7 Participants • Adults and children are analyzed separately.	311 Participants n=2228 Participants • Adults and children are analyzed separately.
HIV Positive Adults	6 Participants n=396 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	1 Participants n=221 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	13 Participants n=395 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	2 Participants n=197 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	3 Participants n=191 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	—	—	—	—	—	5 Participants n=187 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	2 Participants n=99 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	4 Participants n=177 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	2 Participants n=99 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	2 Participants n=100 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	—	—	—	—	—	6 Participants n=324 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	8 Participants n=172 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	—	—	54 Participants n=2558 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.
HIV Positive Children	—	—	—	—	—	0 Participants n=403 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=179 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=407 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=202 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=210 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	—	—	—	—	—	0 Participants n=227 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=107 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=237 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=108 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=107 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	—	—	0 Participants n=34 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=7 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.	0 Participants n=2228 Participants • Adults and children are analyzed separately. HIV positive minors were not included in the study.
Number of Participants with Results for Ebola IgG Concentration (Version 4) Adults	394 Participants n=396 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	220 Participants n=221 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	388 Participants n=395 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	197 Participants n=197 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	189 Participants n=191 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	1388 Participants n=1400 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Results for Ebola IgG Concentration (Version 4) Children	—	—	—	—	—	398 Participants n=403 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	177 Participants n=179 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	401 Participants n=407 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	200 Participants n=202 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	209 Participants n=210 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	1385 Participants n=1401 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Ebola IgG Concentration < 66.96 EU/mL (Version 4) Adults	142 Participants n=394 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	78 Participants n=220 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	144 Participants n=388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	66 Participants n=197 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	68 Participants n=189 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	498 Participants n=1388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Ebola IgG Concentration < 66.96 EU/mL (Version 4) Children	—	—	—	—	—	198 Participants n=398 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	87 Participants n=177 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	187 Participants n=401 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	97 Participants n=200 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	101 Participants n=209 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	670 Participants n=1385 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Ebola IgG Concentration >= 200 EU/mL (Version 4.0) Adults	50 Participants n=394 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	38 Participants n=220 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	58 Participants n=388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	32 Participants n=197 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	30 Participants n=189 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	208 Participants n=1388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Number of Participants with Ebola IgG Concentration >= 200 EU/mL (Version 4.0) Children	—	—	—	—	—	43 Participants n=398 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	22 Participants n=177 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	47 Participants n=401 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	19 Participants n=200 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	32 Participants n=209 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	163 Participants n=1385 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Median Ebola IgG Concentration (Version 4.0) Adults	94 EU/mL n=394 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	99 EU/mL n=220 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	92 EU/mL n=388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	94 EU/mL n=197 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	94 EU/mL n=189 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	95 EU/mL n=1388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Median Ebola IgG Concentration (Version 4.0) Children	—	—	—	—	—	67 EU/mL n=398 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	68 EU/mL n=177 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	74 EU/mL n=401 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	69 EU/mL n=200 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	78 EU/mL n=209 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	70 EU/mL n=1385 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Geometric Mean Ebola IgG Concentration (Version 4.0) Adults	85 EU/mL STANDARD_DEVIATION 2.7 • n=394 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	92 EU/mL STANDARD_DEVIATION 2.8 • n=220 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	87 EU/mL STANDARD_DEVIATION 2.7 • n=388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	91 EU/mL STANDARD_DEVIATION 2.7 • n=197 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	87 EU/mL STANDARD_DEVIATION 2.8 • n=189 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	88 EU/mL STANDARD_DEVIATION 2.7 • n=1388 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.
Geometric Mean Ebola IgG Concentration (Version 4.0) Children	—	—	—	—	—	63 EU/mL STANDARD_DEVIATION 3.0 • n=398 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	66 EU/mL STANDARD_DEVIATION 2.8 • n=177 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	67 EU/mL STANDARD_DEVIATION 3.0 • n=401 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	67 EU/mL STANDARD_DEVIATION 3.1 • n=200 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	73 EU/mL STANDARD_DEVIATION 3.1 • n=209 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.	—	—	—	—	—	—	—	—	—	—	—	—	—	—	66 EU/mL STANDARD_DEVIATION 3.0 • n=1385 Participants • The number of participants analyzed reflects the number of participants with baseline Ebola IgG results from Version 4.0 of the protocol. Adults and children were analyzed separately.

PRIMARY outcome

Timeframe: Measured through Month 12

Population: The analysis population only includes participants from version 4.0 of the protocol. Adults and children are analyzed separately. Participants with a missing baseline or 12-month antibody result are excluded. Participants with elevated antibody levels at baseline were not excluded. The placebo group is pooled. Percentages of participants that do not yield whole numbers are the result of rounding.

Outcome measures

Outcome measures
Measure	Protocol Version 4.0 Ad26/MVA n=755 Participants Ad26.ZEBOV first dose (0.5 mL) followed by an MVA-BN-Filo second dose (0.5 mL) at 56 days	Protocol Version 4.0 rVSV n=756 Participants rVSVΔG-ZEBOV-GP first dose (1 mL) followed by placebo second dose (1 mL) at 56 days	Protocol Version 4.0 rVSV Boost n=374 Participants rVSVΔG-ZEBOV-GP first dose(1 mL) followed by an rVSVΔG-ZEBOV-GP dose (1 mL) at 56 days	Protocol Version 4.0 Pooled Placebo n=741 Participants Placebo dose (0.5 mL or 1 mL) followed by a placebo second dose (0.5 mL or 1 mL) at 56 days
Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response Adults	40.9 percentage of participants	75.7 percentage of participants	81.1 percentage of participants	2.7 percentage of participants
Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response Children	78.5 percentage of participants	87.3 percentage of participants	92.6 percentage of participants	3.6 percentage of participants

SECONDARY outcome

Timeframe: Measured through Month 60

SAEs as defined in the protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured through Month 60

Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.

Outcome measures

Outcome data not reported

Adverse Events

Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)

Serious events: 14 serious events

Other events: 296 other events

Deaths: 2 deaths

Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0)

Serious events: 5 serious events

Other events: 291 other events

Deaths: 1 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)

Serious events: 6 serious events

Other events: 320 other events

Deaths: 3 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)

Serious events: 1 serious events

Other events: 155 other events

Deaths: 0 deaths

Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)

Serious events: 5 serious events

Other events: 341 other events

Deaths: 0 deaths

Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0)

Serious events: 8 serious events

Other events: 298 other events

Deaths: 2 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)

Serious events: 9 serious events

Other events: 350 other events

Deaths: 3 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)

Serious events: 3 serious events

Other events: 179 other events

Deaths: 0 deaths

Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)

Serious events: 12 serious events

Other events: 142 other events

Deaths: 1 deaths

Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0)

Serious events: 6 serious events

Other events: 151 other events

Deaths: 0 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)

Serious events: 6 serious events

Other events: 148 other events

Deaths: 0 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)

Serious events: 2 serious events

Other events: 80 other events

Deaths: 0 deaths

Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)

Serious events: 4 serious events

Other events: 167 other events

Deaths: 0 deaths

Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0)

Serious events: 7 serious events

Other events: 143 other events

Deaths: 1 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)

Serious events: 6 serious events

Other events: 186 other events

Deaths: 1 deaths

rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)

Serious events: 1 serious events

Other events: 84 other events

Deaths: 0 deaths

Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)

Serious events: 6 serious events

Other events: 232 other events

Deaths: 0 deaths

Placebo (0.5 mL) - Adults (v2.0)

Serious events: 5 serious events

Other events: 97 other events

Deaths: 1 deaths

Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo (0.5 mL) - Children (v2.0)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) n=396 participants at risk Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) n=412 participants at risk Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) n=395 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) n=197 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) n=403 participants at risk Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh	Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) n=389 participants at risk Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) n=407 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) n=202 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) n=187 participants at risk Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) n=199 participants at risk Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) n=177 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) n=99 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) n=227 participants at risk Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) n=214 participants at risk Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) n=237 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) n=108 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) n=324 participants at risk Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v2.0) n=172 participants at risk Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) n=34 participants at risk Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v2.0) n=7 participants at risk Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
Pregnancy, puerperium and perinatal conditions ABORTION INCOMPLETE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders test	0.25% 1/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations ABSCESS LIMB	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders ABDOMINAL HERNIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/199 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS INCOMPLETE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/199 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders ACUTE ABDOMEN	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.51% 1/197 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.44% 1/227 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.42% 1/237 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.24% 1/412 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders ANAEMIA; MALARIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/202 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations APPENDICITIS	1.5% 6/396 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.49% 2/412 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/403 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.51% 2/389 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.1% 2/177 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.44% 1/227 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.93% 2/214 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.42% 1/237 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.93% 1/108 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.9% 1/34 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders APPENDICITIS; VAGINAL DISCHARGE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.42% 1/237 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/199 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Respiratory, thoracic and mediastinal disorders ASTHMATIC CRISIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.42% 1/237 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Eye disorders BLINDNESS UNILATERAL	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/202 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications BURNS FIRST DEGREE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.44% 1/227 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications BURNS SECOND DEGREE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations CELLULITIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.24% 1/412 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.58% 1/172 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.26% 1/389 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders COMPARTMENT SYNDROME; HUMERUS FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.0% 1/99 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders DEATH	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.26% 1/389 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.49% 2/407 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.58% 1/172 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders DIABETES MELLITUS; URINARY TRACT INFECTION	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.56% 1/177 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders DIARRHOEA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.58% 1/172 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders DROWNING	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.47% 1/214 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Pregnancy, puerperium and perinatal conditions ECTOPIC PREGNANCY	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications EYE INJURY	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/202 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications FRACTURE; TIBIA FRACTURE; FIBULA FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/403 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations GASTROENTERITIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/199 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders GASTROINTESTINAL OBSTRUCTION	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders GENITAL HAEMORRHAGE; UTERINE CONTRACTIONS DURING PREGNANCY	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.44% 1/227 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.24% 1/412 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications HEAD INJURY; JAW FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.56% 1/177 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations HIV INFECTION	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders HYPERTENSION; DIABETES MELLITUS INADEQUATE CONTROL; KETOACIDOSIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.56% 1/177 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.58% 1/172 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders INGUINAL HERNIA; INGUINAL HERNIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders INGUINAL HERNIA, OBSTRUCTIVE; INGUINAL HERNIA	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications LIMB INJURY; WOUND SECRETION	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations MALARIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/403 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.26% 1/389 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.42% 1/237 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders MALARIA; ACUTE ABDOMEN; ANAEMIA OF PREGNANCY	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.47% 1/214 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations MALARIA; GENITAL INFECTION; APPENDICITIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/199 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.56% 1/177 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.47% 1/214 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Pregnancy, puerperium and perinatal conditions OBSTRUCTED LABOUR	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.47% 1/214 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders PERITONEAL HAEMORRHAGE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations PERITONITIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders PERITONITIS; GASTRIC PERFORATION	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations PNEUMONIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.26% 1/389 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Pregnancy, puerperium and perinatal conditions PREMATURE SEPARATION OF PLACENTA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.31% 1/324 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations PULMONARY TUBERCULOSIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders PYREXIA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/202 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications RADIUS FRACTURE; ULNA FRACTURE	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.50% 1/199 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations SALMONELLOSIS; SALPINGITIS; PYELONEPHRITIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations SEPSIS	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/395 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Blood and lymphatic system disorders SICKLE CELL ANAEMIA WITH CRISIS	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.26% 1/389 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.58% 1/172 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications SNAKE BITE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.47% 1/214 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders SUBILEUS; MALNUTRITION; FURUNCLE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/403 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations TYPHOID FEVER	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/407 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders UTERINE CONTRACTIONS DURING PREGNANCY; ABDOMINAL PAIN; PELVIC PAIN	0.25% 1/396 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.0% 1/99 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications VENOM POISONING	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.26% 1/389 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Infections and infestations WOUND INFECTION	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.25% 1/403 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/237 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/396 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/412 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/395 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/197 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/403 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/389 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/407 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/202 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/187 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/199 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/177 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/227 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.42% 1/237 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/108 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/324 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/172 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.

Other adverse events

Other adverse events
Measure	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) n=396 participants at risk Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0) n=412 participants at risk Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) n=395 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) n=197 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) n=403 participants at risk Protocol Version 4.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh	Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0) n=389 participants at risk Protocol Version 4.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) n=407 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) n=202 participants at risk Protocol Version 4.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) n=187 participants at risk Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0) n=199 participants at risk Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) n=177 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) n=99 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) n=227 participants at risk Protocol Version 3.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0) n=214 participants at risk Protocol Version 3.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL or 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) n=237 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) n=108 participants at risk Protocol Version 3.0 Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56. rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) n=324 participants at risk Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm	Placebo (0.5 mL) - Adults (v2.0) n=172 participants at risk Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) n=34 participants at risk Protocol Version 2.0 Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56. Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh	Placebo (0.5 mL) - Children (v2.0) n=7 participants at risk Protocol Version 2.0 Participants will receive placebo at Day 0 followed by a placebo boost at Day 56. Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh
Musculoskeletal and connective tissue disorders Arthralgia	19.9% 79/396 • Number of events 109 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.3% 63/412 • Number of events 82 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.8% 94/395 • Number of events 128 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.8% 45/197 • Number of events 64 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.9% 28/403 • Number of events 41 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.6% 18/389 • Number of events 29 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.3% 38/407 • Number of events 61 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.9% 14/202 • Number of events 21 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	27.8% 52/187 • Number of events 78 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	24.1% 48/199 • Number of events 70 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	32.2% 57/177 • Number of events 84 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	29.3% 29/99 • Number of events 42 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.6% 24/227 • Number of events 32 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.0% 15/214 • Number of events 19 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.1% 31/237 • Number of events 51 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.1% 12/108 • Number of events 21 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.4% 66/324 • Number of events 99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	12.8% 22/172 • Number of events 31 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.8% 4/34 • Number of events 10 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders Abdominal pain	17.7% 70/396 • Number of events 88 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	18.7% 77/412 • Number of events 99 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.3% 80/395 • Number of events 107 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.8% 39/197 • Number of events 52 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.8% 92/403 • Number of events 169 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.7% 69/389 • Number of events 127 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.8% 97/407 • Number of events 184 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	21.8% 44/202 • Number of events 95 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	21.9% 41/187 • Number of events 57 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	18.1% 36/199 • Number of events 49 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	21.5% 38/177 • Number of events 47 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.2% 17/99 • Number of events 27 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.3% 53/227 • Number of events 90 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.4% 48/214 • Number of events 88 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.6% 56/237 • Number of events 102 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.2% 24/108 • Number of events 35 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.3% 43/324 • Number of events 60 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.4% 23/172 • Number of events 30 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.6% 7/34 • Number of events 9 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.3% 1/7 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders Chills	12.9% 51/396 • Number of events 55 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.7% 48/412 • Number of events 57 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.5% 81/395 • Number of events 97 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	18.8% 37/197 • Number of events 42 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.9% 72/403 • Number of events 114 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.2% 59/389 • Number of events 85 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.7% 80/407 • Number of events 128 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	16.8% 34/202 • Number of events 48 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.2% 21/187 • Number of events 24 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.6% 21/199 • Number of events 25 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.5% 31/177 • Number of events 40 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.1% 14/99 • Number of events 17 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	16.3% 37/227 • Number of events 50 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.8% 21/214 • Number of events 32 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.2% 36/237 • Number of events 52 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.1% 12/108 • Number of events 17 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	12.3% 40/324 • Number of events 45 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.3% 16/172 • Number of events 17 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.8% 3/34 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	28.6% 2/7 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders Crying	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.0% 26/137 • Number of events 39 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.0% 15/136 • Number of events 28 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.0% 27/123 • Number of events 48 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.7% 14/71 • Number of events 26 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.0% 1/25 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.2% 1/24 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.8% 5/24 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.1% 1/9 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	— 0/0 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Metabolism and nutrition disorders Decreased appetite	13.9% 55/396 • Number of events 69 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.1% 54/412 • Number of events 61 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.5% 77/395 • Number of events 98 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	16.2% 32/197 • Number of events 41 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.3% 94/403 • Number of events 162 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.6% 80/389 • Number of events 127 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	29.5% 120/407 • Number of events 220 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	29.2% 59/202 • Number of events 118 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.8% 37/187 • Number of events 58 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.6% 39/199 • Number of events 55 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	29.9% 53/177 • Number of events 73 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	24.2% 24/99 • Number of events 29 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.9% 52/227 • Number of events 82 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.5% 31/214 • Number of events 48 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	24.5% 58/237 • Number of events 110 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	24.1% 26/108 • Number of events 41 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.5% 47/324 • Number of events 58 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	12.2% 21/172 • Number of events 27 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.6% 6/34 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders Diarrhoea	3.0% 12/396 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.6% 19/412 • Number of events 20 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.8% 19/395 • Number of events 21 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.6% 7/197 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.5% 22/403 • Number of events 40 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.3% 40/389 • Number of events 56 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.4% 30/407 • Number of events 39 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.4% 21/202 • Number of events 28 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.9% 11/187 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.5% 9/199 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.5% 8/177 • Number of events 8 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.0% 3/99 • Number of events 4 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.5% 8/227 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.4% 18/214 • Number of events 25 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.2% 17/237 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.6% 5/108 • Number of events 7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.8% 9/324 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.9% 5/172 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.9% 2/34 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Nervous system disorders Dizziness	11.1% 44/396 • Number of events 53 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.2% 46/412 • Number of events 52 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.2% 60/395 • Number of events 67 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.6% 15/197 • Number of events 18 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.4% 38/403 • Number of events 70 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.9% 27/389 • Number of events 49 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.5% 55/407 • Number of events 96 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.4% 19/202 • Number of events 33 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.9% 26/187 • Number of events 35 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.6% 35/199 • Number of events 49 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	18.6% 33/177 • Number of events 45 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	16.2% 16/99 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.0% 9/227 • Number of events 15 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.9% 17/214 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.9% 21/237 • Number of events 29 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.3% 9/108 • Number of events 16 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.7% 38/324 • Number of events 45 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.9% 17/172 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.9% 2/34 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	28.6% 2/7 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders Fatigue	23.0% 91/396 • Number of events 119 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.4% 84/412 • Number of events 106 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	28.6% 113/395 • Number of events 151 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	31.0% 61/197 • Number of events 86 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.3% 82/403 • Number of events 131 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.0% 66/389 • Number of events 110 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	27.3% 111/407 • Number of events 186 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	21.8% 44/202 • Number of events 73 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	35.8% 67/187 • Number of events 107 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	34.7% 69/199 • Number of events 100 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	41.8% 74/177 • Number of events 106 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	37.4% 37/99 • Number of events 57 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	24.2% 55/227 • Number of events 96 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.7% 25/214 • Number of events 34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	25.3% 60/237 • Number of events 100 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	28.7% 31/108 • Number of events 55 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	21.0% 68/324 • Number of events 115 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.7% 39/172 • Number of events 57 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.7% 5/34 • Number of events 9 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	28.6% 2/7 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Nervous system disorders Headache	54.3% 215/396 • Number of events 376 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	52.9% 218/412 • Number of events 398 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	63.3% 250/395 • Number of events 447 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	58.9% 116/197 • Number of events 203 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	41.9% 169/403 • Number of events 438 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	38.6% 150/389 • Number of events 375 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	53.3% 217/407 • Number of events 555 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	48.0% 97/202 • Number of events 245 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	58.8% 110/187 • Number of events 212 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	57.3% 114/199 • Number of events 209 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	64.4% 114/177 • Number of events 214 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	66.7% 66/99 • Number of events 116 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	45.4% 103/227 • Number of events 220 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	43.5% 93/214 • Number of events 173 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	52.3% 124/237 • Number of events 264 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	51.9% 56/108 • Number of events 138 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	50.3% 163/324 • Number of events 264 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	41.3% 71/172 • Number of events 115 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	50.0% 17/34 • Number of events 30 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	28.6% 2/7 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.8% 7/396 • Number of events 7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.5% 6/412 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.8% 7/395 • Number of events 9 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.0% 6/197 • Number of events 7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.2% 13/403 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.8% 11/389 • Number of events 15 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.7% 15/407 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.5% 3/202 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.1% 4/187 • Number of events 4 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.5% 5/199 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.5% 8/177 • Number of events 8 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.0% 2/99 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.8% 4/227 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.3% 5/214 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.8% 9/237 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.6% 5/108 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.4% 11/324 • Number of events 12 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.1% 7/172 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.3% 1/7 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders Mouth ulceration	1.0% 4/396 • Number of events 4 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.7% 7/412 • Number of events 8 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.0% 12/395 • Number of events 14 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.5% 3/197 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.7% 7/403 • Number of events 15 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.6% 10/389 • Number of events 13 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.7% 7/407 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.5% 9/202 • Number of events 21 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.3% 8/187 • Number of events 8 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.5% 11/199 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.0% 7/177 • Number of events 7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.1% 6/99 • Number of events 7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.2% 5/227 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.2% 9/214 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.2% 10/237 • Number of events 13 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.8% 3/108 • Number of events 8 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.4% 11/324 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	1.2% 2/172 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Musculoskeletal and connective tissue disorders Myalgia	26.5% 105/396 • Number of events 142 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	22.3% 92/412 • Number of events 115 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	34.9% 138/395 • Number of events 188 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	34.5% 68/197 • Number of events 92 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.4% 62/403 • Number of events 93 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.8% 38/389 • Number of events 46 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	19.2% 78/407 • Number of events 112 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.8% 32/202 • Number of events 51 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	29.9% 56/187 • Number of events 79 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	27.1% 54/199 • Number of events 72 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	34.5% 61/177 • Number of events 79 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	33.3% 33/99 • Number of events 40 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	15.0% 34/227 • Number of events 42 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.2% 24/214 • Number of events 28 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	21.1% 50/237 • Number of events 68 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.1% 25/108 • Number of events 36 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.5% 76/324 • Number of events 86 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.4% 23/172 • Number of events 24 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	17.6% 6/34 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.3% 1/7 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders Nausea	6.8% 27/396 • Number of events 31 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.0% 37/412 • Number of events 46 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	12.9% 51/395 • Number of events 61 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.2% 22/197 • Number of events 29 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.5% 26/403 • Number of events 42 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.7% 26/389 • Number of events 37 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.6% 39/407 • Number of events 61 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.4% 11/202 • Number of events 15 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.2% 19/187 • Number of events 23 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.0% 16/199 • Number of events 20 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.7% 19/177 • Number of events 26 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.1% 11/99 • Number of events 14 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.4% 19/227 • Number of events 26 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.1% 11/214 • Number of events 17 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.5% 13/237 • Number of events 16 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.3% 10/108 • Number of events 15 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.9% 19/324 • Number of events 23 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.5% 18/172 • Number of events 24 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.8% 3/34 • Number of events 3 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.3% 1/7 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
General disorders Pyrexia	39.4% 156/396 • Number of events 204 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	32.8% 135/412 • Number of events 188 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	45.6% 180/395 • Number of events 241 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	44.2% 87/197 • Number of events 130 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	64.8% 261/403 • Number of events 534 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	49.4% 192/389 • Number of events 399 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	68.3% 278/407 • Number of events 620 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	71.8% 145/202 • Number of events 314 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	29.4% 55/187 • Number of events 79 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	26.1% 52/199 • Number of events 82 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	39.0% 69/177 • Number of events 97 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	34.3% 34/99 • Number of events 43 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	38.8% 88/227 • Number of events 161 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	31.8% 68/214 • Number of events 101 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	48.1% 114/237 • Number of events 207 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	41.7% 45/108 • Number of events 84 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	20.4% 66/324 • Number of events 79 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.0% 24/172 • Number of events 27 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	23.5% 8/34 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	14.3% 1/7 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Skin and subcutaneous tissue disorders Skin lesion	4.5% 18/396 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.1% 17/412 • Number of events 23 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.6% 18/395 • Number of events 21 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.6% 9/197 • Number of events 10 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.9% 40/403 • Number of events 60 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.5% 41/389 • Number of events 64 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.1% 37/407 • Number of events 58 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.4% 15/202 • Number of events 26 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	12.3% 23/187 • Number of events 25 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.0% 14/199 • Number of events 22 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.9% 21/177 • Number of events 27 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.1% 6/99 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.6% 24/227 • Number of events 40 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.4% 18/214 • Number of events 25 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	9.7% 23/237 • Number of events 33 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.1% 12/108 • Number of events 18 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.2% 17/324 • Number of events 20 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	5.8% 10/172 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.9% 1/34 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.
Gastrointestinal disorders Vomiting	3.8% 15/396 • Number of events 16 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.9% 16/412 • Number of events 16 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.3% 25/395 • Number of events 28 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	6.1% 12/197 • Number of events 13 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	12.9% 52/403 • Number of events 70 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	10.0% 39/389 • Number of events 53 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	13.5% 55/407 • Number of events 77 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.9% 24/202 • Number of events 38 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.53% 1/187 • Number of events 1 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	4.5% 9/199 • Number of events 11 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	3.4% 6/177 • Number of events 6 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.0% 2/99 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.8% 20/227 • Number of events 27 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	7.0% 15/214 • Number of events 21 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	8.0% 19/237 • Number of events 29 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	11.1% 12/108 • Number of events 14 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.62% 2/324 • Number of events 2 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	2.9% 5/172 • Number of events 5 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/34 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.	0.00% 0/7 • 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete. AEs of grade 1 or 2 severity other than injection site reactions and targeted symptoms were not collected. Systematically assessed AEs were collected via standard checklist.

Additional Information

John Tierney, Director of Office of the Clinical Research Policy and Regulatory Operations (OCRPRO)

National Institute of Allergy and Infectious Diseases (NIAID)

Phone: 301.451.5136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place