Trial Outcomes & Findings for Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (NCT NCT02720094)

NCT ID: NCT02720094

Last Updated: 2025-10-10

Results Overview

All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 4570 participants
• Primary outcome timeframe: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
• Results posted on: 2025-10-10

Participant Flow

Participant milestones

Measure	Cabotegravir In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Overall Study STARTED	2283	2287
Overall Study Ongoing	2210	2203
Overall Study Terminated From the Study	67	78
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	2276	2281

Reasons for withdrawal

Measure	Cabotegravir In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Overall Study Ongoing	2210	2203
Overall Study Scheduled exit visit/end of study	2	1
Overall Study Death	4	7
Overall Study Withdrawal by Subject	55	56
Overall Study Lost to Follow-up	2	7
Overall Study Physician Decision	1	3
Overall Study Inappropriate enrollment	1	3
Overall Study Relocation	1	1

Baseline Characteristics

Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

Baseline characteristics by cohort

Measure	Cabotegravir n=2283 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2287 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	Total n=4570 Participants Total of all reporting groups
Age, Continuous	26 years n=5 Participants	26 years n=7 Participants	26 years n=5 Participants
Age, Customized 18-24 years	931 Participants n=5 Participants	915 Participants n=7 Participants	1846 Participants n=5 Participants
Age, Customized 25-34 years	940 Participants n=5 Participants	931 Participants n=7 Participants	1871 Participants n=5 Participants
Age, Customized 35-44 years	285 Participants n=5 Participants	313 Participants n=7 Participants	598 Participants n=5 Participants
Age, Customized 45-54 years	103 Participants n=5 Participants	109 Participants n=7 Participants	212 Participants n=5 Participants
Age, Customized 55-60 years	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Age, Customized 61+ years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized <30 years	1572 Participants n=5 Participants	1510 Participants n=7 Participants	3082 Participants n=5 Participants
Age, Customized >=30 years	711 Participants n=5 Participants	777 Participants n=7 Participants	1488 Participants n=5 Participants
Sex/Gender, Customized Men who have sex with men	2014 Participants n=5 Participants	1982 Participants n=7 Participants	3996 Participants n=5 Participants
Sex/Gender, Customized Transgender women	266 Participants n=5 Participants	304 Participants n=7 Participants	570 Participants n=5 Participants
Sex/Gender, Customized Prefer not to answer	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1043 Participants n=5 Participants	1067 Participants n=7 Participants	2110 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1240 Participants n=5 Participants	1219 Participants n=7 Participants	2459 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	616 Participants n=5 Participants	600 Participants n=7 Participants	1216 Participants n=5 Participants
Race (NIH/OMB) Asian	417 Participants n=5 Participants	406 Participants n=7 Participants	823 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	565 Participants n=5 Participants	569 Participants n=7 Participants	1134 Participants n=5 Participants
Race (NIH/OMB) White	618 Participants n=5 Participants	649 Participants n=7 Participants	1267 Participants n=5 Participants
Race (NIH/OMB) More than one race	49 Participants n=5 Participants	54 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Argentina	169 participants n=5 Participants	168 participants n=7 Participants	337 participants n=5 Participants
Region of Enrollment Vietnam	100 participants n=5 Participants	99 participants n=7 Participants	199 participants n=5 Participants
Region of Enrollment United States	850 participants n=5 Participants	851 participants n=7 Participants	1701 participants n=5 Participants
Region of Enrollment Brazil	395 participants n=5 Participants	401 participants n=7 Participants	796 participants n=5 Participants
Region of Enrollment Africa	78 participants n=5 Participants	74 participants n=7 Participants	152 participants n=5 Participants
Region of Enrollment Thailand	275 participants n=5 Participants	278 participants n=7 Participants	553 participants n=5 Participants
Region of Enrollment Peru	416 participants n=5 Participants	416 participants n=7 Participants	832 participants n=5 Participants
Marital Status Married/Civil Union/Legal Partnership	79 Participants n=5 Participants	98 Participants n=7 Participants	177 Participants n=5 Participants
Marital Status Living with Primary or Main Partner	138 Participants n=5 Participants	154 Participants n=7 Participants	292 Participants n=5 Participants
Marital Status Have Primary or Main Partner, not Living Together	171 Participants n=5 Participants	165 Participants n=7 Participants	336 Participants n=5 Participants
Marital Status Single/Divorced/Widowed	1889 Participants n=5 Participants	1865 Participants n=7 Participants	3754 Participants n=5 Participants
Marital Status Other	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Education No Schooling	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Education Primary School, not complete	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Education Primary School, complete	16 Participants n=5 Participants	25 Participants n=7 Participants	41 Participants n=5 Participants
Education Secondary School, not complete	119 Participants n=5 Participants	113 Participants n=7 Participants	232 Participants n=5 Participants
Education Secondary School, complete	371 Participants n=5 Participants	410 Participants n=7 Participants	781 Participants n=5 Participants
Education Technical Training, not complete	74 Participants n=5 Participants	79 Participants n=7 Participants	153 Participants n=5 Participants
Education Technical Training, complete	113 Participants n=5 Participants	109 Participants n=7 Participants	222 Participants n=5 Participants
Education College/University or Higher, not complete	708 Participants n=5 Participants	712 Participants n=7 Participants	1420 Participants n=5 Participants
Education College/University or Higher, complete	868 Participants n=5 Participants	816 Participants n=7 Participants	1684 Participants n=5 Participants

PRIMARY outcome

Timeframe: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.

Population: mITT Population (Steps 1 and 2): Participants who were inappropriately enrolled are excluded. Participants who were found by the EAC to be HIV infected at enrollment are excluded.

All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).

Outcome measures

Measure	Cabotegravir n=2280 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2281 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Number of Participants With Documented Incident HIV Infections During Steps 1 and 2	13 Participants	39 Participants

PRIMARY outcome

Timeframe: Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).

Population: Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.

The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.

Outcome measures

Measure	Cabotegravir n=2280 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2282 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events	2106 Participants	2116 Participants

SECONDARY outcome

Timeframe: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.

Population: Injection step 2 efficacy: The subgroup of the mITT population who received at least one injection and had at least one HIV result assessed after the first injection visit.

Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population

Outcome measures

Measure	Cabotegravir n=2114 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2079 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Number of Participants With Documented Incident HIV Infections in Step 2	8 Participants	37 Participants

SECONDARY outcome

Timeframe: Reported week 57 (injection visit #8) and week 105 (injection visit #14)

Population: All subjects who received at least one dose of study product, and for whom have results for creatine and creatinine clearance at enrollment AND for at least one of the following two time points: Week 57 and Week 105.

Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.

Outcome measures

Measure	Cabotegravir n=1364 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=1360 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes From Baseline in Creatinine and Creatinine Clearance Levels Week 105 (Injection #14)	0.90 umol/L Interval -5.3 to 8.8	2.30 umol/L Interval -3.5 to 8.8
Changes From Baseline in Creatinine and Creatinine Clearance Levels Week 57 (Injection #8)	0.90 umol/L Interval -5.3 to 7.1	1.70 umol/L Interval -4.4 to 7.9

SECONDARY outcome

Timeframe: Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)

Population: Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.

Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.

Outcome measures

Measure	Cabotegravir n=2280 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2282 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)	73 Participants	96 Participants

SECONDARY outcome

Timeframe: Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center

Population: All participants in the mITT population who acquired HIV, including those who were found to have acquired HIV prior to randomization.

Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.

Outcome measures

Measure	Cabotegravir n=14 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=42 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters Any resistance	8 Participants	13 Participants
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters PI resistance	0 Participants	0 Participants
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters NNRTI resistance	3 Participants	10 Participants
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters NRTI resistance	1 Participants	6 Participants
Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters INSTI resistance	6 Participants	0 Participants

SECONDARY outcome

Timeframe: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).

Population: Enrolled participants with available data at each visit

Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.

Outcome measures

Measure	Cabotegravir n=2282 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2284 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes in Weight From Baseline Week 5 (Injection #1)	0.4 Kg Interval -0.7 to 1.5	0.1 Kg Interval -1.0 to 1.1
Changes in Weight From Baseline Week 9 (Injection #2)	0.5 Kg Interval -0.9 to 1.8	0.0 Kg Interval -1.3 to 1.3
Changes in Weight From Baseline Week 17 (Injection #3)	0.7 Kg Interval -0.9 to 2.4	0.0 Kg Interval -1.7 to 1.6
Changes in Weight From Baseline Week 25 (Injection #4)	0.9 Kg Interval -1.0 to 2.7	-0.2 Kg Interval -2.0 to 1.8
Changes in Weight From Baseline Week 33 (Injection #5)	1.0 Kg Interval -1.0 to 3.1	0.0 Kg Interval -2.2 to 1.9
Changes in Weight From Baseline Week 41 (Injection #6)	1.2 Kg Interval -1.0 to 3.5	0.0 Kg Interval -2.1 to 2.4
Changes in Weight From Baseline Week 49 (Injection #7)	1.5 Kg Interval -0.9 to 3.8	0.0 Kg Interval -2.3 to 2.6
Changes in Weight From Baseline Week 57 (Injection #8)	1.2 Kg Interval -1.2 to 4.0	0.2 Kg Interval -2.5 to 2.5
Changes in Weight From Baseline Week 65 (Injection #9)	1.7 Kg Interval -0.9 to 4.5	0.5 Kg Interval -2.4 to 3.1
Changes in Weight From Baseline Week #73 (Injection #10)	1.8 Kg Interval -0.9 to 5.0	0.5 Kg Interval -2.3 to 3.3
Changes in Weight From Baseline Week 81 (Injection #11)	2.0 Kg Interval -1.0 to 5.2	0.5 Kg Interval -2.3 to 3.9
Changes in Weight From Baseline Week 89 (Injection #12)	2.2 Kg Interval -0.9 to 5.8	0.5 Kg Interval -2.3 to 3.9
Changes in Weight From Baseline Week 97 (Injection #13)	2.1 Kg Interval -0.9 to 5.9	1.0 Kg Interval -1.9 to 4.0
Changes in Weight From Baseline Week #105 (Injection #14)	2.1 Kg Interval -1.0 to 6.3	0.9 Kg Interval -2.0 to 4.8
Changes in Weight From Baseline Week 113 (Injection #15)	2.6 Kg Interval -0.5 to 7.2	1.4 Kg Interval -2.3 to 5.3
Changes in Weight From Baseline Week 121 (Injection #16)	2.8 Kg Interval -0.8 to 7.2	1.0 Kg Interval -2.5 to 5.1
Changes in Weight From Baseline Week 129 (Injection #17)	2.9 Kg Interval -0.9 to 7.1	1.3 Kg Interval -2.1 to 4.8
Changes in Weight From Baseline Week 137 (Injection #18)	2.7 Kg Interval -1.0 to 7.8	1.2 Kg Interval -2.5 to 5.2
Changes in Weight From Baseline Week 145 (Injection #19)	2.7 Kg Interval -1.4 to 7.3	1.9 Kg Interval -1.9 to 5.4
Changes in Weight From Baseline Week 153 (Injection #20)	2.9 Kg Interval -0.2 to 7.5	0.7 Kg Interval -2.0 to 6.4

SECONDARY outcome

Timeframe: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).

Population: Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.

Outcome measures

Measure	Cabotegravir n=2281 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2285 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes in Systolic Blood Pressure From Baseline Week 5 (Injection #1)	0.0 mmHg Interval -8.0 to 7.0	0.0 mmHg Interval -8.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 9 (Injection #2)	0.0 mmHg Interval -9.0 to 7.0	-1.0 mmHg Interval -9.0 to 6.0
Changes in Systolic Blood Pressure From Baseline Week 17 (Injection #3)	0.0 mmHg Interval -8.0 to 7.0	0.0 mmHg Interval -9.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 25 (Injection #4)	0.0 mmHg Interval -8.0 to 7.0	0.0 mmHg Interval -9.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 33 (Injection #5)	0.0 mmHg Interval -8.0 to 8.0	0.0 mmHg Interval -9.0 to 6.0
Changes in Systolic Blood Pressure From Baseline Week 41 (Injection #6)	0.0 mmHg Interval -9.0 to 8.0	0.0 mmHg Interval -8.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 49 (Injection #7)	0.0 mmHg Interval -9.0 to 8.0	0.0 mmHg Interval -9.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 57 (Injection #8)	0.0 mmHg Interval -8.0 to 8.0	-1.0 mmHg Interval -10.0 to 6.0
Changes in Systolic Blood Pressure From Baseline Week 65 (Injection #9)	0.0 mmHg Interval -8.0 to 7.0	0.0 mmHg Interval -9.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 73 (Injection #10)	0.0 mmHg Interval -8.0 to 9.0	0.0 mmHg Interval -8.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 81 (Injection #11)	0.5 mmHg Interval -8.0 to 9.0	0.0 mmHg Interval -8.0 to 8.0
Changes in Systolic Blood Pressure From Baseline Week 89 (Injection #12)	0.0 mmHg Interval -8.0 to 9.0	-1.0 mmHg Interval -9.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 97 (Injection #13)	1.0 mmHg Interval -7.0 to 9.0	0.0 mmHg Interval -8.0 to 7.0
Changes in Systolic Blood Pressure From Baseline Week 105 (Injection #14)	1.0 mmHg Interval -7.0 to 9.0	0.0 mmHg Interval -8.0 to 8.0
Changes in Systolic Blood Pressure From Baseline Week 113 (Injection #15)	0.0 mmHg Interval -6.0 to 8.0	0.0 mmHg Interval -8.0 to 8.0
Changes in Systolic Blood Pressure From Baseline Week 121 (Injection #16)	1.0 mmHg Interval -7.0 to 8.0	0.0 mmHg Interval -8.0 to 9.0
Changes in Systolic Blood Pressure From Baseline Week 129 (Injection #17)	2.0 mmHg Interval -7.0 to 10.0	2.0 mmHg Interval -6.5 to 11.0
Changes in Systolic Blood Pressure From Baseline Week 137 (Injection #18)	0.0 mmHg Interval -7.0 to 9.0	2.0 mmHg Interval -8.0 to 10.0
Changes in Systolic Blood Pressure From Baseline Week 145 (Injection #19)	1.0 mmHg Interval -7.0 to 11.0	3.5 mmHg Interval -8.0 to 10.0
Changes in Systolic Blood Pressure From Baseline Week 153 (Injection #20)	2.0 mmHg Interval -4.0 to 9.0	2.0 mmHg Interval -9.0 to 13.0

SECONDARY outcome

Timeframe: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).

Population: Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.

Outcome measures

Measure	Cabotegravir n=2281 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2285 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes in Diastolic Blood Pressure From Baseline Week 5 (Injection #1)	0.0 mmHg Interval -7.0 to 5.0	-1.0 mmHg Interval -7.0 to 4.0
Changes in Diastolic Blood Pressure From Baseline Week 9 (Injection #2)	0.0 mmHg Interval -7.0 to 4.0	0.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 17 (Injection #3)	0.0 mmHg Interval -7.0 to 5.0	0.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 25 (Injection #4)	0.0 mmHg Interval -7.0 to 5.0	0.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 33 (Injection #5)	0.0 mmHg Interval -7.0 to 6.0	0.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 41 (Injection #6)	0.0 mmHg Interval -7.0 to 5.0	-1.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 49 (Injection #7)	0.0 mmHg Interval -7.0 to 5.0	-1.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 57 (Injection #8)	0.0 mmHg Interval -6.0 to 6.0	0.0 mmHg Interval -7.0 to 6.0
Changes in Diastolic Blood Pressure From Baseline Week 65 (Injection #9)	0.0 mmHg Interval -7.0 to 5.0	0.0 mmHg Interval -7.0 to 6.0
Changes in Diastolic Blood Pressure From Baseline Week 73 (Injection #10)	0.0 mmHg Interval -6.0 to 5.0	0.0 mmHg Interval -7.0 to 6.0
Changes in Diastolic Blood Pressure From Baseline Week 81 (Injection #11)	0.0 mmHg Interval -6.0 to 6.0	-1.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 89 (Injection #12)	0.0 mmHg Interval -7.0 to 5.0	-1.0 mmHg Interval -6.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 97 (Injection #13)	0.0 mmHg Interval -7.0 to 6.0	-1.0 mmHg Interval -8.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 105 (Injection #14)	0.5 mmHg Interval -6.0 to 7.0	0.0 mmHg Interval -6.0 to 6.0
Changes in Diastolic Blood Pressure From Baseline Week 113 (Injection #15)	1.0 mmHg Interval -6.0 to 7.0	0.0 mmHg Interval -6.0 to 7.0
Changes in Diastolic Blood Pressure From Baseline Week 121 (Injection #16)	0.0 mmHg Interval -6.0 to 6.5	-1.0 mmHg Interval -7.0 to 6.0
Changes in Diastolic Blood Pressure From Baseline Week 129 (Injection #17)	1.0 mmHg Interval -6.0 to 9.0	0.0 mmHg Interval -7.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 137 (Injection #18)	0.0 mmHg Interval -5.0 to 7.0	0.0 mmHg Interval -6.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 145 (Injection #19)	1.0 mmHg Interval -5.0 to 8.0	-2.0 mmHg Interval -6.0 to 5.0
Changes in Diastolic Blood Pressure From Baseline Week 153 (Injection #20)	2.5 mmHg Interval -6.0 to 8.0	0.0 mmHg Interval -4.0 to 4.0

SECONDARY outcome

Timeframe: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).

Population: Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.

Outcome measures

Measure	Cabotegravir n=2281 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2285 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes in Pulse Rate From Baseline Week 5 (Injection #1)	2.0 beats/min Interval -4.0 to 9.0	1.0 beats/min Interval -5.0 to 8.0
Changes in Pulse Rate From Baseline Week 9 (Injection #2)	2.0 beats/min Interval -5.0 to 9.0	1.0 beats/min Interval -5.0 to 8.0
Changes in Pulse Rate From Baseline Week 17 (Injection #3)	2.0 beats/min Interval -5.0 to 9.0	2.0 beats/min Interval -5.0 to 9.0
Changes in Pulse Rate From Baseline Week 25 (Injection #4)	2.0 beats/min Interval -5.0 to 9.0	2.0 beats/min Interval -5.0 to 9.0
Changes in Pulse Rate From Baseline Week 33 (Injection #5)	3.0 beats/min Interval -5.0 to 10.0	2.0 beats/min Interval -5.0 to 9.0
Changes in Pulse Rate From Baseline Week 41 (Injection #6)	2.0 beats/min Interval -4.0 to 10.0	2.0 beats/min Interval -5.0 to 9.0
Changes in Pulse Rate From Baseline Week 49 (Injection #7)	3.0 beats/min Interval -4.0 to 10.0	2.0 beats/min Interval -5.0 to 10.0
Changes in Pulse Rate From Baseline Week 57 (Injection #8)	2.0 beats/min Interval -6.0 to 8.0	0.0 beats/min Interval -6.0 to 7.0
Changes in Pulse Rate From Baseline Week 65 (Injection #9)	2.0 beats/min Interval -4.0 to 10.0	2.0 beats/min Interval -5.0 to 10.0
Changes in Pulse Rate From Baseline Week 73 (Injection #10)	3.0 beats/min Interval -4.0 to 11.0	2.0 beats/min Interval -4.0 to 10.0
Changes in Pulse Rate From Baseline Week 81 (Injection #11)	3.0 beats/min Interval -4.0 to 11.0	2.0 beats/min Interval -5.0 to 10.0
Changes in Pulse Rate From Baseline Week 89 (Injection #12)	3.0 beats/min Interval -4.0 to 11.0	2.0 beats/min Interval -5.0 to 10.0
Changes in Pulse Rate From Baseline Week 97 (Injection #13)	3.0 beats/min Interval -5.0 to 12.0	2.0 beats/min Interval -4.0 to 11.0
Changes in Pulse Rate From Baseline Week 105 (Injection #14)	2.0 beats/min Interval -6.0 to 9.0	1.0 beats/min Interval -6.0 to 7.0
Changes in Pulse Rate From Baseline Week 113 (Injection #15)	4.0 beats/min Interval -4.0 to 11.0	2.0 beats/min Interval -4.0 to 10.0
Changes in Pulse Rate From Baseline Week 121 (Injection #16)	3.0 beats/min Interval -4.5 to 12.0	3.0 beats/min Interval -6.0 to 11.0
Changes in Pulse Rate From Baseline Week 129 (Injection #17)	2.0 beats/min Interval -5.5 to 11.0	2.0 beats/min Interval -6.0 to 10.0
Changes in Pulse Rate From Baseline Week 137 (Injection #18)	5.5 beats/min Interval -3.0 to 12.0	3.0 beats/min Interval -5.0 to 10.0
Changes in Pulse Rate From Baseline Week 145 (Injection #19)	4.0 beats/min Interval -4.0 to 13.0	2.0 beats/min Interval -6.0 to 11.0
Changes in Pulse Rate From Baseline Week 153 (Injection #20)	4.0 beats/min Interval -7.0 to 12.0	3.5 beats/min Interval -8.0 to 11.0

SECONDARY outcome

Timeframe: Assessed at weeks 57 and 105.

Population: Participants who were inappropriately enrolled are excluded. Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.

Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.

Outcome measures

Measure	Cabotegravir n=2282 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2284 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes in Fasting Glucose Levels From Baseline Week 57	1.0 mg/dL Interval -5.0 to 7.0	0.0 mg/dL Interval -6.0 to 6.0
Changes in Fasting Glucose Levels From Baseline Week 105	1.0 mg/dL Interval -5.0 to 8.0	1.8 mg/dL Interval -6.0 to 8.0

SECONDARY outcome

Timeframe: Assessed at weeks 57 and 105.

Population: Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.

Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.

Outcome measures

Measure	Cabotegravir n=2282 Participants In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2284 Participants In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Changes in Fasting Lipid Profile From Baseline Total Cholesterol Week 57	1.0 mg/dL Interval -15.0 to 16.0	-10.0 mg/dL Interval -26.0 to 6.2
Changes in Fasting Lipid Profile From Baseline Total Cholesterol Week 105	4.0 mg/dL Interval -13.0 to 19.0	-7.5 mg/dL Interval -26.0 to 9.0
Changes in Fasting Lipid Profile From Baseline Trigylcerides Week 57	2.7 mg/dL Interval -20.0 to 28.0	0.0 mg/dL Interval -23.0 to 25.0
Changes in Fasting Lipid Profile From Baseline Trigylcerides Week 105	7.5 mg/dL Interval -19.0 to 32.0	2.0 mg/dL Interval -21.0 to 31.0
Changes in Fasting Lipid Profile From Baseline LDL Week 57	1.0 mg/dL Interval -12.4 to 15.0	-6.0 mg/dL Interval -19.7 to 7.0
Changes in Fasting Lipid Profile From Baseline LDL Week 105	3.0 mg/dL Interval -12.0 to 18.0	-4.0 mg/dL Interval -20.0 to 11.0
Changes in Fasting Lipid Profile From Baseline HDL Week57	-0.2 mg/dL Interval -6.0 to 5.0	-3.0 mg/dL Interval -9.0 to 3.0
Changes in Fasting Lipid Profile From Baseline HDL Week 105	-0.9 mg/dL Interval -6.8 to 5.0	-3.0 mg/dL Interval -9.0 to 2.6

Adverse Events

Cabotegravir

Serious events: 117 serious events

Other events: 2103 other events

Deaths: 4 deaths

TDF/FTC

Serious events: 109 serious events

Other events: 2114 other events

Deaths: 7 deaths

Serious adverse events

Measure	Cabotegravir n=2281 participants at risk In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2285 participants at risk In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
Blood and lymphatic system disorders Any Event in SOC	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Immune thrombocytopenia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Acute myocardial infarction	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Any Event in SOC	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Arrhythmia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Atrial fibrillation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Atrial flutter	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Cardiac disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Cardiopulmonary failure	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Myocardial infarction	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Myocardial ischaemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Congenital, familial and genetic disorders Any Event in SOC	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Congenital, familial and genetic disorders Thyroglossal cyst	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Any Event in SOC	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Vertigo	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Any Event in SOC	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Ulcerative keratitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Alcoholic pancreatitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal fissure	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal fistula	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Any Event in SOC	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Cannabinoid hyperemesis syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Enteritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Enterocolitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Food poisoning	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gastritis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Haemorrhoids	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Haemorrhoids thrombosed	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Inflammatory bowel disease	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Intussusception	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Pancreatitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Small intestinal obstruction	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Any Event in SOC	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Pyrexia	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Acute hepatic failure	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Any Event in SOC	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Cholecystitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Cholecystitis acute	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abdominal abscess	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abscess limb	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acute hepatitis B	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acute hepatitis C	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Any Event in SOC	2.1% 48/2281 • Number of events 50 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.7% 38/2285 • Number of events 40 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Appendicitis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Arthritis gonococcal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bronchitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cellulitis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Dengue fever	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Dengue haemorrhagic fever	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Febrile infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Hepatitis A	0.13% 3/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Influenza	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Kidney infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lymphogranuloma venereum	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Nasopharyngitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Osteomyelitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis media	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Parotitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngitis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngitis bacterial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngotonsillitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pneumonia	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pneumonia bacterial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pulmonary tuberculosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pyelonephritis acute	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Respiratory tract infection viral	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Secondary syphilis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Shigella infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Sinusitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Subcutaneous abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tonsillitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tonsillitis bacterial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tooth abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Upper respiratory tract infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral pericarditis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Ankle fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Any Event in SOC	0.57% 13/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 26/2285 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Burns second degree	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Concussion	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Craniocerebral injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Extradural haematoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Gun shot wound	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Head injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Jaw fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Multiple injuries	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Overdose	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Stab wound	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tendon rupture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Alanine aminotransferase increased	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Any Event in SOC	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatine phosphokinase increased	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Lipase increased	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Platelet count decreased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Any Event in SOC	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hyperglycaemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypokalaemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Any Event in SOC	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Arthralgia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Any Event in SOC	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Any Event in SOC	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Brain stem infarction	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Cerebral haemorrhage	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Dizziness	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Lumbar radiculopathy	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Sciatica	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Seizure	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Status epilepticus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Acute stress disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Adjustment disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Affective disorder	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Aggression	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Alcoholism	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Any Event in SOC	1.0% 23/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.2% 28/2285 • Number of events 32 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Bipolar disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Borderline personality disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Depression	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Depression suicidal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Impulse-control disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Major depression	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Mental status changes	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Psychotic disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Substance abuse	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Substance-induced psychotic disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Suicidal ideation	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Suicide attempt	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Any Event in SOC	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Renal colic	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Ureterolithiasis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Any Event in SOC	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Apnoea	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Any Event in SOC	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Urticaria	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Any Event in SOC	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Deep vein thrombosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Vascular occlusion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Other adverse events

Measure	Cabotegravir n=2281 participants at risk In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter	TDF/FTC n=2285 participants at risk In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
General disorders Pain	0.53% 12/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Anaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Antiphospholipid syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Any Event in SOC	1.4% 33/2281 • Number of events 36 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.5% 35/2285 • Number of events 40 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Cyclic neutropenia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Iron deficiency anaemia	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Lymphadenitis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Lymphadenopathy	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Lymphocytic infiltration	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Lymphopenia	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Neutropenia	0.66% 15/2281 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 21 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Blood and lymphatic system disorders Thrombocytopenia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Angina pectoris	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Any Event in SOC	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Arrhythmia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Bradycardia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Coronary artery disease	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Extrasystoles	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Palpitations	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Pericarditis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Sinus tachycardia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Tachycardia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Cardiac disorders Ventricular extrasystoles	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Congenital, familial and genetic disorders Any Event in SOC	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Congenital, familial and genetic disorders Gilbert's syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Congenital, familial and genetic disorders Steatocystoma multiplex	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Congenital, familial and genetic disorders Thalassaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Any Event in SOC	0.96% 22/2281 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Cerumen impaction	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Ear discomfort	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Ear pain	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Ear pruritus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Ear swelling	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Eustachian tube dysfunction	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Motion sickness	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Tinnitus	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Tympanic membrane disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Tympanic membrane perforation	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Vertigo	0.31% 7/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Vertigo positional	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Endocrine disorders Any Event in SOC	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Endocrine disorders Hyperparathyroidism	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Endocrine disorders Hyperprolactinaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Endocrine disorders Hyperthyroidism	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Endocrine disorders Hypothyroidism	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Any Event in SOC	0.96% 22/2281 • Number of events 30 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.88% 20/2285 • Number of events 22 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Blepharitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Chalazion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Chorioretinopathy	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Conjunctival haemorrhage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Conjunctivitis allergic	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Dry eye	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eye allergy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eye discharge	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eye inflammation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eye irritation	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eye pain	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eye pruritus	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Eyelid oedema	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Giant papillary conjunctivitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Glaucoma	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Hypermetropia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Iritis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Keratitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Lacrimation increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Myopia	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Ocular hyperaemia	0.18% 4/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Retinal detachment	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Strabismus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Swelling of eyelid	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Ulcerative keratitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Vision blurred	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Visual acuity reduced	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Eye disorders Visual impairment	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Abdominal discomfort	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Abdominal distension	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Abdominal pain	1.1% 26/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.0% 23/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Abdominal pain lower	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Abdominal pain upper	1.1% 24/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal fissure	0.88% 20/2281 • Number of events 20 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.2% 28/2285 • Number of events 31 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal fistula	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Peripheral swelling	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal haemorrhage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal inflammation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal polyp	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal pruritus	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal skin tags	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anal ulcer	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Angular cheilitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Anorectal discomfort	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Any Event in SOC	19.7% 450/2281 • Number of events 638 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	21.1% 481/2285 • Number of events 706 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Aphthous ulcer	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Change of bowel habit	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Chronic gastritis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Colitis	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Colitis ulcerative	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Constipation	0.61% 14/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Cyclic vomiting syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Dental caries	0.61% 14/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Dental necrosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Diarrhoea	4.9% 111/2281 • Number of events 129 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	5.2% 119/2285 • Number of events 152 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Dysbiosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Dyspepsia	1.4% 32/2281 • Number of events 38 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.4% 31/2285 • Number of events 33 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Dysphagia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Enteritis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Enterocolitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Eructation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Flatulence	0.53% 12/2281 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Food poisoning	1.6% 37/2281 • Number of events 38 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.8% 41/2285 • Number of events 41 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gastritis	1.3% 29/2281 • Number of events 40 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gastrointestinal inflammation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.0% 23/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gingival pain	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gingival recession	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Gingival ulceration	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Glossitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Glossodynia	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Haematochezia	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Haemorrhoids	1.8% 42/2281 • Number of events 45 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.9% 44/2285 • Number of events 46 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Hyperchlorhydria	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Inguinal hernia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Irritable bowel syndrome	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Lip exfoliation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Lip swelling	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Loose tooth	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Mouth cyst	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Mouth ulceration	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Mucous stools	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Nausea	0.96% 22/2281 • Number of events 22 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.7% 39/2285 • Number of events 48 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Odynophagia	0.66% 15/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Oesophageal haemorrhage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Oesophagitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Oral pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Oral pruritus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Pancreatitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Parotid duct obstruction	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Peptic ulcer	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Periodontal disease	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Proctalgia	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Proctitis	0.61% 14/2281 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Rectal discharge	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Rectal fissure	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Rectal haemorrhage	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Rectal spasm	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Rectal tenesmus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Rectal ulcer	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Salivary gland enlargement	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Sialocele	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Steatorrhoea	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Stomatitis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Tooth deposit	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Tooth impacted	0.48% 11/2281 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Toothache	1.2% 28/2281 • Number of events 33 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.9% 44/2285 • Number of events 48 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Umbilical hernia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Uvulitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Gastrointestinal disorders Vomiting	0.48% 11/2281 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.96% 22/2285 • Number of events 22 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Adverse drug reaction	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Adverse food reaction	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Any Event in SOC	10.0% 229/2281 • Number of events 359 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	6.5% 149/2285 • Number of events 174 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Application site pain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Asthenia	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Chest discomfort	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Chest pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Chills	0.18% 4/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Cyst	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Discomfort	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Drug withdrawal syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Face oedema	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Facial pain	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Fatigue	1.4% 31/2281 • Number of events 37 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Feeling abnormal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Fibrosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Gait disturbance	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Hangover	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Hernia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Induration	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Influenza like illness	1.2% 28/2281 • Number of events 38 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.88% 20/2285 • Number of events 23 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Injury associated with device	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Lithiasis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Malaise	1.3% 30/2281 • Number of events 44 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Medical device site ulcer	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Mucosal disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Nodule	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Non-cardiac chest pain	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Oedema peripheral	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Polyp	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Puncture site pain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Puncture site swelling	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Pyrexia	5.3% 121/2281 • Number of events 186 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.7% 62/2285 • Number of events 69 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Swelling face	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Vaccination site pain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
General disorders Xerosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Any Event in SOC	0.70% 16/2281 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Cholecystitis acute	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Cholelithiasis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Deficiency of bile secretion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Drug-induced liver injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Hepatic fibrosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Hepatic steatosis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Hepatitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Hyperbilirubinaemia	0.22% 5/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Jaundice	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Hepatobiliary disorders Nonalcoholic fatty liver disease	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Allergy to animal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Allergy to arthropod bite	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Allergy to arthropod sting	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Allergy to chemicals	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Any Event in SOC	2.6% 59/2281 • Number of events 64 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.3% 53/2285 • Number of events 54 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Autoimmune disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Drug hypersensitivity	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Food allergy	0.61% 14/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Hypersensitivity	0.57% 13/2281 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Jarisch-Herxheimer reaction	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Mite allergy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Multiple allergies	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Mycotic allergy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Perfume sensitivity	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Seasonal allergy	0.79% 18/2281 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.83% 19/2285 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Immune system disorders Serum sickness	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abdominal abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abscess jaw	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abscess limb	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abscess neck	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abscess of eyelid	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Abscess rupture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acanthamoeba keratitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acarodermatitis	1.1% 26/2281 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.9% 43/2285 • Number of events 48 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acute hepatitis B	0.13% 3/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acute hepatitis C	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Acute sinusitis	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Amoebic dysentery	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal abscess	0.22% 5/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal candidiasis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal chlamydia infection	10.9% 248/2281 • Number of events 297 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	11.7% 267/2285 • Number of events 326 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal fistula infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal fungal infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anal infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Anorectal human papilloma virus infection	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Any Event in SOC	59.6% 1360/2281 • Number of events 3515 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	58.8% 1344/2285 • Number of events 3456 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Appendicitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Arboviral infection	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Asymptomatic COVID-19	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Atypical pneumonia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bacteraemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bacterial diarrhoea	0.22% 5/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bacterial infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bacterial prostatitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bacterial urethritis	0.39% 9/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bacteriuria	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Balanitis candida	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Beta haemolytic streptococcal infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Blastocystis infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Body tinea	0.31% 7/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bone abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Breast abscess	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bronchitis	1.2% 28/2281 • Number of events 30 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.4% 31/2285 • Number of events 32 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bronchitis bacterial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bronchitis viral	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Bullous impetigo	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations COVID-19	0.61% 14/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Campylobacter infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Candida infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Candida urethritis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Carbuncle	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cellulitis	0.96% 22/2281 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cellulitis staphylococcal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Chancroid	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Chest wall abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Chikungunya virus infection	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Chlamydial infection	2.9% 66/2281 • Number of events 77 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.9% 66/2285 • Number of events 74 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Chronic hepatitis C	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Chronic sinusitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Conjunctivitis	0.83% 19/2281 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Conjunctivitis bacterial	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Conjunctivitis viral	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cryptosporidiosis infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cystitis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cystitis bacterial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Cytomegalovirus infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Dengue fever	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Dengue haemorrhagic fever	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Dermatophytosis	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Diarrhoea infectious	0.53% 12/2281 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Diverticulitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Dysentery	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Ear infection	0.57% 13/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Ear infection bacterial	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Ear lobe infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Enterobiasis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Enterovirus infection	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Epididymitis	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Epstein-Barr virus infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Erysipelas	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Escherichia urinary tract infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations External ear cellulitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Eye infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Eye infection bacterial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Eye infection gonococcal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Eye infection staphylococcal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Febrile infection	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Folliculitis	0.70% 16/2281 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Fungal infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Fungal skin infection	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Furuncle	0.66% 15/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastric infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis	3.6% 83/2281 • Number of events 88 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	3.8% 87/2285 • Number of events 94 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis bacterial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis cryptosporidial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis rotavirus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis shigella	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastroenteritis viral	0.96% 22/2281 • Number of events 22 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastrointestinal infection	0.48% 11/2281 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastrointestinal protozoal infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gastrointestinal viral infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital candidiasis	0.26% 6/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital herpes	1.0% 23/2281 • Number of events 33 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.96% 22/2285 • Number of events 36 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital herpes simplex	0.48% 11/2281 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital herpes zoster	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital infection bacterial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genital infection fungal	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genitourinary chlamydia infection	1.5% 34/2281 • Number of events 37 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.0% 23/2285 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Genitourinary tract gonococcal infection	0.92% 21/2281 • Number of events 21 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Giardiasis	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gingival abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gingivitis	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gonococcal infection	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Gonorrhoea	2.2% 51/2281 • Number of events 60 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.1% 49/2285 • Number of events 57 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Groin infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Hand-foot-and-mouth disease	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Helicobacter gastritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Helicobacter infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Helminthic infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Hepatitis A	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Hepatitis E	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Hepatitis syphilitic	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Herpes dermatitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Herpes simplex	0.61% 14/2281 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Herpes virus infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Herpes zoster	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Hordeolum	0.75% 17/2281 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.83% 19/2285 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Impetigo	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Infected bite	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Infected dermal cyst	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Infection parasitic	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Infectious mononucleosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Infectious thyroiditis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Influenza	2.7% 62/2281 • Number of events 64 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.8% 63/2285 • Number of events 65 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Labyrinthitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Large intestine infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Laryngitis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Laryngitis viral	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Latent syphilis	2.5% 56/2281 • Number of events 58 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.2% 50/2285 • Number of events 54 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Latent tuberculosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lice infestation	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Localised infection	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lower respiratory tract infection	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lyme disease	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lymph node tuberculosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lymphadenitis bacterial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lymphangitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Lymphogranuloma venereum	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Malassezia infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Mastitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Measles	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Molluscum contagiosum	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Mononucleosis syndrome	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Mumps	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Mycoplasma genitalium infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Myringitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Nasal herpes	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Nasopharyngitis	12.9% 295/2281 • Number of events 421 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	11.9% 273/2285 • Number of events 380 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Onychomycosis	0.57% 13/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oral candidiasis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oral fungal infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oral herpes	1.1% 26/2281 • Number of events 29 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oral infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oral pustule	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oral viral infection	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Orchitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood phosphorus decreased	3.9% 90/2281 • Number of events 118 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	4.8% 110/2285 • Number of events 152 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Oropharyngeal gonococcal infection	1.4% 33/2281 • Number of events 35 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.2% 27/2285 • Number of events 29 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Osteomyelitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis externa	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis externa bacterial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis externa fungal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis media	0.31% 7/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis media acute	0.31% 7/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis media bacterial	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Otitis media viral	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Papilloma viral infection	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Parasitic gastroenteritis	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Paronychia	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Parotitis	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pelvic abscess	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Penile infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pericoronitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Periodontitis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Periorbital cellulitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Perirectal abscess	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Peritonsillar abscess	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngeal chlamydia infection	0.48% 11/2281 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngitis	4.6% 104/2281 • Number of events 124 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	3.9% 89/2285 • Number of events 101 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngitis bacterial	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngitis streptococcal	2.0% 46/2281 • Number of events 52 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.3% 29/2285 • Number of events 34 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pharyngotonsillitis	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pilonidal cyst	0.09% 2/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pneumococcal sepsis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pneumonia	0.53% 12/2281 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pneumonia bacterial	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Post procedural infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Postoperative wound infection	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Primary syphilis	1.0% 23/2281 • Number of events 25 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.0% 23/2285 • Number of events 25 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Proctitis bacterial	0.04% 1/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Proctitis chlamydial	1.5% 34/2281 • Number of events 39 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.8% 41/2285 • Number of events 47 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Proctitis gonococcal	8.8% 200/2281 • Number of events 235 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	9.8% 225/2285 • Number of events 256 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Proctitis herpes	0.13% 3/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pseudomonas infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pulmonary tuberculosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pulpitis dental	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Puncture site infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Purulent discharge	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pyelonephritis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Pyelonephritis acute	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Rectal abscess	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Respiratory syncytial virus infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Respiratory tract infection	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Respiratory tract infection viral	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Rhinitis	1.1% 26/2281 • Number of events 35 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.79% 18/2285 • Number of events 22 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Rocky mountain spotted fever	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Root canal infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Scrotal abscess	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Secondary syphilis	1.1% 26/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.4% 31/2285 • Number of events 31 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Severe acute respiratory syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Sexually transmitted disease	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Shigella infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Sialoadenitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Sinusitis	1.9% 44/2281 • Number of events 50 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.1% 47/2285 • Number of events 52 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Sinusitis bacterial	0.18% 4/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Skin bacterial infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Skin infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Staphylococcal infection	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Staphylococcal skin infection	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Streptococcal infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Strongyloidiasis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Subcutaneous abscess	0.53% 12/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Suspected COVID-19	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Syphilis	8.2% 187/2281 • Number of events 203 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.7% 198/2285 • Number of events 219 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Syphilis anal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Syphilis genital	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tinea cruris	0.53% 12/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tinea infection	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tinea pedis	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tinea versicolour	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tonsillitis	2.5% 56/2281 • Number of events 63 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.6% 59/2285 • Number of events 67 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tonsillitis bacterial	1.0% 23/2281 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tonsillitis streptococcal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tooth abscess	0.66% 15/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tooth infection	0.66% 15/2281 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tracheitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Tracheobronchitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Trichomoniasis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Typhoid fever	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Upper respiratory tract infection	7.7% 176/2281 • Number of events 245 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	7.4% 170/2285 • Number of events 223 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Upper respiratory tract infection bacterial	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Urethritis	2.2% 51/2281 • Number of events 60 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.5% 58/2285 • Number of events 63 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Urethritis chlamydial	2.5% 56/2281 • Number of events 62 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.6% 60/2285 • Number of events 66 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Urethritis gonococcal	2.8% 64/2281 • Number of events 70 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.2% 51/2285 • Number of events 61 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Urinary tract infection	1.1% 25/2281 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.0% 23/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Urinary tract infection bacterial	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Varicella	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral diarrhoea	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral infection	2.5% 58/2281 • Number of events 62 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.1% 48/2285 • Number of events 65 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral pharyngitis	0.61% 14/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral rash	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral rhinitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral sinusitis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral tonsillitis	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Viral upper respiratory tract infection	2.6% 59/2281 • Number of events 77 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.9% 66/2285 • Number of events 77 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Vulvitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Wound infection	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Infections and infestations Wound infection bacterial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Alcohol poisoning	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Anal injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Animal bite	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Animal scratch	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Any Event in SOC	12.5% 286/2281 • Number of events 420 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	13.9% 317/2285 • Number of events 437 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Arthropod bite	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.79% 18/2285 • Number of events 20 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Arthropod sting	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Back injury	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Bite	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Bone contusion	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Burn oesophageal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Burns first degree	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Burns second degree	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Buttock injury	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Cartilage injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Chest injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Clavicle fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Concussion	0.18% 4/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Contusion	0.70% 16/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.79% 18/2285 • Number of events 20 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Craniocerebral injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Ear injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Exposure to communicable disease	0.75% 17/2281 • Number of events 21 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.61% 14/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Exposure to contaminated air	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Exposure to toxic agent	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Eye contusion	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Eye injury	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Eyelid injury	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Face injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Facial bones fracture	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Foot fracture	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Forearm fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Foreign body in eye	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Fractured coccyx	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Hand fracture	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Head injury	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Joint dislocation	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Joint injury	0.53% 12/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Ligament rupture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Ligament sprain	1.5% 34/2281 • Number of events 39 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.6% 36/2285 • Number of events 38 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Limb injury	0.61% 14/2281 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.88% 20/2285 • Number of events 21 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Lip injury	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Meniscus injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Mouth injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Multiple injuries	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Muscle contusion	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Muscle strain	1.4% 33/2281 • Number of events 35 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.4% 31/2285 • Number of events 36 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Nail avulsion	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Nail injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Neck injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Overdose	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Penis injury	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Perineal injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Periorbital haematoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural constipation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural contusion	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural discomfort	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural fever	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural inflammation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post procedural swelling	0.39% 9/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post vaccination syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Post-traumatic pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Postoperative wound complication	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Prescribed overdose	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Procedural nausea	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Procedural pain	2.9% 66/2281 • Number of events 73 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	3.1% 71/2285 • Number of events 82 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Radius fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Retinal injury	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Rib fracture	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Scar	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Skin abrasion	0.88% 20/2281 • Number of events 22 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Skin injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Skin laceration	1.1% 25/2281 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 25 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Skin wound	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Skull fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Stab wound	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Stress fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Sunburn	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Thermal burn	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tibia fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tooth fracture	0.44% 10/2281 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Traumatic haematoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Upper limb fracture	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Wound	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Wound dehiscence	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Injury, poisoning and procedural complications Wrist fracture	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Alanine aminotransferase increased	7.0% 159/2281 • Number of events 189 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.4% 192/2285 • Number of events 238 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Amylase increased	6.5% 148/2281 • Number of events 282 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	7.4% 169/2285 • Number of events 292 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Any Event in SOC	82.9% 1892/2281 • Number of events 8346 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	83.8% 1914/2285 • Number of events 9028 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Aspartate aminotransferase increased	8.2% 188/2281 • Number of events 216 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.6% 197/2285 • Number of events 228 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Bilirubin conjugated increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood alkaline phosphatase increased	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood bicarbonate decreased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood bilirubin increased	3.9% 89/2281 • Number of events 150 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	4.7% 108/2285 • Number of events 169 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood calcium decreased	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood calcium increased	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood cholesterol increased	1.8% 41/2281 • Number of events 42 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatine decreased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatine increased	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatine phosphokinase decreased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatine phosphokinase increased	21.2% 484/2281 • Number of events 678 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	20.6% 470/2285 • Number of events 682 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatinine decreased	0.70% 16/2281 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood creatinine increased	16.7% 382/2281 • Number of events 711 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	18.7% 428/2285 • Number of events 783 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood glucose decreased	4.3% 98/2281 • Number of events 119 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	4.5% 103/2285 • Number of events 130 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood glucose increased	8.7% 199/2281 • Number of events 302 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	5.4% 123/2285 • Number of events 190 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood phosphorus increased	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood potassium decreased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood potassium increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood pressure decreased	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood pressure diastolic abnormal	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood pressure diastolic increased	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood pressure increased	0.96% 22/2281 • Number of events 29 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.83% 19/2285 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood pressure systolic increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood sodium decreased	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood sodium increased	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood testosterone decreased	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood triglycerides increased	1.4% 31/2281 • Number of events 33 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.2% 27/2285 • Number of events 30 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Blood uric acid increased	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Creatinine renal clearance decreased	69.7% 1589/2281 • Number of events 4777 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	73.1% 1671/2285 • Number of events 5351 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Creatinine renal clearance increased	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Electrocardiogram QT prolonged	0.13% 3/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Glomerular filtration rate decreased	0.53% 12/2281 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.83% 19/2285 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Glucose urine present	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations HLA-B*27 positive	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Haemoglobin decreased	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Heart rate increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Lipase increased	10.9% 249/2281 • Number of events 457 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	11.4% 260/2285 • Number of events 468 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Lipids increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Low density lipoprotein increased	2.6% 60/2281 • Number of events 61 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.2% 28/2285 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Lymphocyte count decreased	0.53% 12/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Lymphocyte count increased	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Neutrophil count decreased	0.96% 22/2281 • Number of events 38 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.5% 35/2285 • Number of events 61 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Neutrophil count increased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Platelet count decreased	0.26% 6/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Protein urine	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Protein urine present	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Red blood cells urine	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations Weight decreased	0.79% 18/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.8% 41/2285 • Number of events 57 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Investigations White blood cell count decreased	0.09% 2/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Abnormal loss of weight	1.5% 35/2281 • Number of events 44 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.8% 63/2285 • Number of events 94 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Any Event in SOC	5.6% 128/2281 • Number of events 169 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	7.0% 160/2285 • Number of events 228 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Dairy intolerance	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Decreased appetite	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Dehydration	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Diabetes mellitus	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Dyslipidaemia	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Fructose intolerance	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Glucose tolerance impaired	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Gout	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypercholesterolaemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hyperglycaemia	0.88% 20/2281 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.79% 18/2285 • Number of events 34 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hyperlipasaemia	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hyperlipidaemia	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypoglycaemia	1.0% 23/2281 • Number of events 30 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypokalaemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hyponatraemia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Hypophosphataemia	0.35% 8/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.74% 17/2285 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Increased appetite	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Iron deficiency	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Lipid metabolism disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Obesity	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Overweight	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Metabolism and nutrition disorders Vitamin D deficiency	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Any Event in SOC	10.8% 247/2281 • Number of events 319 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	11.2% 255/2285 • Number of events 325 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 42/2281 • Number of events 44 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.9% 44/2285 • Number of events 50 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Arthritis	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Back pain	3.3% 75/2281 • Number of events 90 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	3.9% 88/2285 • Number of events 93 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Bone pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Bursitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Chondritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Costochondritis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Flank pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Intervertebral disc displacement	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Joint swelling	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Muscle contracture	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Muscle spasms	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Muscle tightness	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Muscular weakness	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.31% 7/2281 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 58/2281 • Number of events 60 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.3% 53/2285 • Number of events 63 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Myositis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Neck mass	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Neck pain	0.53% 12/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Osteochondritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Pain in extremity	0.75% 17/2281 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.92% 21/2285 • Number of events 23 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Pain in jaw	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Periarthritis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Spinal pain	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Spinal retrolisthesis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Synovial cyst	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Tendon disorder	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Tendon pain	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Tendonitis	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Torticollis	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Trigger finger	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.83% 19/2281 • Number of events 21 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.92% 21/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Any Event in SOC	1.4% 32/2281 • Number of events 38 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.4% 33/2285 • Number of events 39 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of skin	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral papilloma	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile wart	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Amputation stump pain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Any Event in SOC	12.0% 273/2281 • Number of events 388 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	11.8% 270/2285 • Number of events 387 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Balance disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Burning sensation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Carpal tunnel syndrome	0.09% 2/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Cerebrospinal fluid leakage	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Cerebrovascular accident	0.13% 3/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Cervical radiculopathy	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Cluster headache	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Cubital tunnel syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Disturbance in attention	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Dizziness	0.48% 11/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.79% 18/2285 • Number of events 20 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Dizziness postural	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Dystonia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Essential tremor	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Exertional headache	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Facial paralysis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Headache	8.9% 204/2281 • Number of events 275 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.5% 195/2285 • Number of events 273 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Hypoaesthesia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Lethargy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Loss of consciousness	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Lumbar radiculopathy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Migraine	0.79% 18/2281 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.57% 13/2285 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Migraine with aura	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Nerve compression	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Neuralgia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Neuropathy peripheral	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Paraesthesia	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Presyncope	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Psychomotor hyperactivity	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Radiculopathy	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Restless legs syndrome	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Sciatica	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Seizure	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Seizure like phenomena	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Sinus headache	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Somnolence	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Syncope	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Taste disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Nervous system disorders Tension headache	1.1% 24/2281 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.74% 17/2285 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Abnormal dreams	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Acute stress disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Adjustment disorder	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Adjustment disorder with depressed mood	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Alcohol abuse	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Alcoholism	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Anxiety	2.5% 57/2281 • Number of events 62 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.0% 45/2285 • Number of events 45 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Anxiety disorder	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Any Event in SOC	9.6% 220/2281 • Number of events 285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.6% 196/2285 • Number of events 247 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Attention deficit hyperactivity disorder	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Bipolar II disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Bipolar disorder	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Borderline personality disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Bulimia nervosa	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Confusional state	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Depressed mood	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Depression	2.9% 66/2281 • Number of events 67 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.2% 50/2285 • Number of events 52 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Depressive symptom	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Discouragement	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Drug abuse	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Drug dependence	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Drug use disorder	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Emotional disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Emotional distress	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Flashback	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Gambling disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Gender dysphoria	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Generalised anxiety disorder	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Grief reaction	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Hallucination, auditory	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Hallucinations, mixed	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Homicidal ideation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Initial insomnia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Insomnia	2.1% 49/2281 • Number of events 56 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.3% 53/2285 • Number of events 56 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Intentional self-injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Irritability	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Libido decreased	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Major depression	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Mania	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Mental disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Mental fatigue	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Mood swings	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Nightmare	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Panic attack	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Panic disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Panic reaction	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Persistent depressive disorder	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Post-traumatic stress disorder	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Psychotic disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Seasonal affective disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Sleep disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Stress	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Substance abuse	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Suicidal ideation	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Suicide attempt	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Psychiatric disorders Thinking abnormal	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Acute kidney injury	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Any Event in SOC	3.4% 77/2281 • Number of events 92 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	3.4% 78/2285 • Number of events 85 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Calculus bladder	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Calculus urinary	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Choluria	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Chromaturia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Dysuria	1.1% 26/2281 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.74% 17/2285 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Glycosuria	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Haematuria	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Micturition urgency	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Nephrolithiasis	0.31% 7/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Nocturia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Pollakiuria	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Polyuria	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Proteinuria	0.39% 9/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Renal colic	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Urethral discharge	1.0% 23/2281 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 15 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Urethral syndrome	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Urethritis noninfective	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Renal and urinary disorders Urinary retention	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Any Event in SOC	2.4% 55/2281 • Number of events 67 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.4% 54/2285 • Number of events 60 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Balanoposthitis	0.31% 7/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Breast enlargement	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Breast pain	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Erectile dysfunction	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Erection increased	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Galactorrhoea	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Genital burning sensation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Genital cyst	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Genital discomfort	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Genital paraesthesia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Genital rash	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Genital ulceration	0.39% 9/2281 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.35% 8/2285 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Gynaecomastia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Nipple inflammation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Nipple pain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile blister	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile burning sensation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile discharge	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile erosion	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile oedema	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile rash	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Penile swelling	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Prostatitis	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Pruritus genital	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Scrotal dermatitis	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Scrotal pain	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Scrotal ulcer	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Testicular cyst	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Testicular oedema	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Testicular pain	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Vaginal prolapse	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Reproductive system and breast disorders Varicocele	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.79% 18/2281 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.70% 16/2285 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.18% 4/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Allergic pharyngitis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Allergic respiratory disease	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.35% 8/2281 • Number of events 8 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Any Event in SOC	8.1% 184/2281 • Number of events 249 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.5% 194/2285 • Number of events 265 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Asthma	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 42/2281 • Number of events 46 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.7% 38/2285 • Number of events 42 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Dry throat	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Hiccups	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.92% 21/2281 • Number of events 23 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Nasal mucosal erosion	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.8% 41/2281 • Number of events 42 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	2.1% 48/2285 • Number of events 50 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Productive cough	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Reflux laryngitis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.4% 32/2281 • Number of events 33 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.3% 29/2285 • Number of events 35 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.70% 16/2281 • Number of events 17 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 26 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.57% 13/2281 • Number of events 13 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.66% 15/2285 • Number of events 16 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Small airways disease	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Sneezing	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.18% 4/2281 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Tonsillar inflammation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Acne	0.79% 18/2281 • Number of events 19 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 25/2285 • Number of events 27 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Acne cystic	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Alopecia	0.44% 10/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Any Event in SOC	6.9% 158/2281 • Number of events 185 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	8.3% 189/2285 • Number of events 219 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Blister	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dermal cyst	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dermatitis	0.44% 10/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.44% 10/2281 • Number of events 11 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.48% 11/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 4 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dermatitis contact	0.39% 9/2281 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.53% 12/2285 • Number of events 12 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dermatitis papillaris capillitii	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Drug eruption	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dry skin	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Ecchymosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Eczema	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Eczema nummular	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Guttate psoriasis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Hidradenitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Ingrown hair	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Lichen nitidus	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Macule	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Night sweats	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Papule	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.39% 9/2285 • Number of events 9 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Penile ulceration	0.26% 6/2281 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.31% 7/2285 • Number of events 7 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Pruritus	0.61% 14/2281 • Number of events 14 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.44% 10/2285 • Number of events 10 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Pseudofolliculitis	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Psoriasis	0.13% 3/2281 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash	1.0% 23/2281 • Number of events 28 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.0% 23/2285 • Number of events 24 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash erythematous	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash macular	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.26% 6/2285 • Number of events 6 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash morbilliform	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash papular	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.22% 5/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash pruritic	0.22% 5/2281 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.18% 4/2285 • Number of events 5 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Sea bather's eruption	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.13% 3/2285 • Number of events 3 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin exfoliation	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin striae	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Solar dermatitis	0.09% 2/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Urticaria	0.70% 16/2281 • Number of events 18 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.83% 19/2285 • Number of events 25 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Urticaria cholinergic	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Urticaria chronic	0.04% 1/2281 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Skin and subcutaneous tissue disorders Xeroderma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Social circumstances Any Event in SOC	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Social circumstances Impaired quality of life	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Social circumstances Substance use	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Any Event in SOC	1.7% 39/2281 • Number of events 47 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.4% 31/2285 • Number of events 37 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Essential hypertension	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Haematoma	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Hot flush	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Hyperaemia	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Hypertension	1.5% 35/2281 • Number of events 43 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	1.1% 24/2285 • Number of events 29 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Hypertensive crisis	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Hypotension	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Peripheral venous disease	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Phlebitis superficial	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.09% 2/2285 • Number of events 2 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders Thrombophlebitis superficial	0.04% 1/2281 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.00% 0/2285 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.
Vascular disorders White coat hypertension	0.00% 0/2281 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	0.04% 1/2285 • Number of events 1 • Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks) Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.

Additional Information

HPTN Statistical Manager

HPTN Statistical & Data Management Center

Phone: 206-667-4004

Email: HPTN-Data-Access@scharp.org

Results disclosure agreements

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