Trial Outcomes & Findings for A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD] (NCT NCT04270747)

Last Updated: 2025-09-10

Results Overview

BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

576 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2025-09-10

Participant Flow

This study was conducted at 102 centers in Canada, Czech Republic, Estonia, Germany, Hong Kong, Hungary, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Poland, Slovakia, Spain, and the United States between 22 June 2020 and 30 January 2023.

Both eyes were assessed at the screening visit for eligibility, and only 1 eye was selected from each participant as the study eye. If both eyes met the eligibility criteria, the study eye was the one with the worse best corrected visual acuity (BCVA).

Participant milestones

Participant milestones
Measure	ABP 938 / ABP 938 Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / Aflibercept Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to remain on aflibercept dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Through Week 16 STARTED	288	288	0
Through Week 16 COMPLETED	273	270	0
Through Week 16 NOT COMPLETED	15	18	0
Post Week 16 STARTED	273	136	134
Post Week 16 Received Treatment	273	136	133
Post Week 16 COMPLETED	251	125	123
Post Week 16 NOT COMPLETED	22	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	ABP 938 / ABP 938 Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / Aflibercept Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to remain on aflibercept dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Through Week 16 Adverse Event	1	2	0
Through Week 16 Death	0	2	0
Through Week 16 Consent Withdrawn	3	3	0
Through Week 16 Physician Decision	1	1	0
Through Week 16 Lost to Follow-up	2	0	0
Through Week 16 Protocol Violation	1	2	0
Through Week 16 Protocol Specified Criteria	6	7	0
Through Week 16 Miscellaneous	1	1	0
Post Week 16 Adverse Event	7	5	1
Post Week 16 Death	2	0	2
Post Week 16 Consent Withdrawn	4	3	6
Post Week 16 Physician Decision	3	1	1
Post Week 16 Lost to Follow-up	2	1	0
Post Week 16 Requirement for Alternative Therapy	1	0	0
Post Week 16 Requirement for Alternative Dosing Schedule	2	1	0
Post Week 16 Miscellaneous	1	0	1

Baseline Characteristics

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABP 938 n=288 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=288 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Total n=576 Participants Total of all reporting groups
Age, Continuous	76.0 Years STANDARD_DEVIATION 7.93 • n=5 Participants	76.0 Years STANDARD_DEVIATION 7.95 • n=7 Participants	76.0 Years STANDARD_DEVIATION 7.93 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	171 Participants n=7 Participants	322 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	117 Participants n=7 Participants	254 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	281 Participants n=5 Participants	275 Participants n=7 Participants	556 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	250 Participants n=5 Participants	248 Participants n=7 Participants	498 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Full Analysis Set: Consisted of all randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were initially randomized. Analysis included participants with available data at Baseline and Week 8.

Outcome measures

Outcome measures
Measure	ABP 938 n=279 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=281 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Mean Change From Baseline in BCVA at Week 8	6.4 Letters Standard Deviation 8.18	6.5 Letters Standard Deviation 8.97	—	—	—

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set (Re-randomized): Consisted of all re-randomized participants, with treatment as the randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and Week 52.

A participant was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score, assessed in the study eye, compared to Baseline.

Outcome measures

Outcome measures
Measure	ABP 938 n=251 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=125 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=123 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Percentage of Participants Who Maintained Vision at Week 52	95.6 Percentage of Participants Interval 93.1 to 98.2	97.6 Percentage of Participants Interval 94.9 to 100.0	95.9 Percentage of Participants Interval 92.5 to 99.4	—	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52

Population: Full Analysis Set (Re-randomized): Consisted of all randomized participants, with treatment as the re-randomized treatment regardless of actual treatment received. Participants were included in the treatment group in which they were re-randomized. Analysis included participants with available data at Baseline and at each timepoint.

BCVA score was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.

Outcome measures

Outcome measures
Measure	ABP 938 n=273 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=136 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=134 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Mean Change From Baseline in BCVA Week 4	5.0 Letters Standard Deviation 6.57	5.4 Letters Standard Deviation 8.35	3.8 Letters Standard Deviation 8.19	—	—
Mean Change From Baseline in BCVA Week 8	6.5 Letters Standard Deviation 8.10	7.6 Letters Standard Deviation 9.30	5.6 Letters Standard Deviation 8.86	—	—
Mean Change From Baseline in BCVA Week 16	6.8 Letters Standard Deviation 8.69	7.5 Letters Standard Deviation 9.31	7.1 Letters Standard Deviation 9.32	—	—
Mean Change From Baseline in BCVA Week 24	7.2 Letters Standard Deviation 9.63	7.1 Letters Standard Deviation 9.30	7.0 Letters Standard Deviation 10.12	—	—
Mean Change From Baseline in BCVA Week 32	7.1 Letters Standard Deviation 11.00	8.7 Letters Standard Deviation 9.21	6.6 Letters Standard Deviation 11.11	—	—
Mean Change From Baseline in BCVA Week 40	7.3 Letters Standard Deviation 11.00	8.1 Letters Standard Deviation 11.00	7.9 Letters Standard Deviation 10.08	—	—
Mean Change From Baseline in BCVA Week 48	7.2 Letters Standard Deviation 11.51	8.7 Letters Standard Deviation 10.84	8.1 Letters Standard Deviation 10.74	—	—
Mean Change From Baseline in BCVA Week 52	7.6 Letters Standard Deviation 11.60	9.4 Letters Standard Deviation 10.18	8.0 Letters Standard Deviation 11.14	—	—

SECONDARY outcome

Timeframe: Week 8

Percentage of participants who gained at least 10 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.

Outcome measures

Outcome measures
Measure	ABP 938 n=279 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=281 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8	29.4 Percentage of participants Interval 24.1 to 34.7	32.7 Percentage of participants Interval 27.3 to 38.2	—	—	—

SECONDARY outcome

Timeframe: Week 52

Percentage of participants who gained at least 15 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.

Outcome measures

Outcome measures
Measure	ABP 938 n=251 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=125 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=123 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52	24.3 Percentage of participants Interval 19.0 to 29.6	29.6 Percentage of participants Interval 21.6 to 37.6	24.4 Percentage of participants Interval 16.8 to 32.0	—	—

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, 24, and 52

CNV area size was measured by fluorescein angiography. Change from Baseline calculated as observed post-baseline value - Baseline value.

Outcome measures

Outcome measures
Measure	ABP 938 n=255 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=127 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=130 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size Week 8	-4.962 mm^2 Standard Deviation 5.1604	-5.479 mm^2 Standard Deviation 5.1023	-5.169 mm^2 Standard Deviation 4.6943	—	—
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size Week 16	-4.089 mm^2 Standard Deviation 5.3668	-5.174 mm^2 Standard Deviation 5.2280	-4.751 mm^2 Standard Deviation 4.8814	—	—
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size Week 24	-4.323 mm^2 Standard Deviation 5.5972	-5.308 mm^2 Standard Deviation 5.6238	-5.121 mm^2 Standard Deviation 5.2776	—	—
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size Week 52	-6.276 mm^2 Standard Deviation 6.2690	-7.280 mm^2 Standard Deviation 5.8262	-6.434 mm^2 Standard Deviation 5.2445	—	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52

CST was defined as the average thickness in the ETDRS central 1 mm diameter subfield (the central subfield) and was measured by spectral domain optical coherence tomography. Change from Baseline calculated as observed post-baseline value - Baseline value.

Outcome measures

Outcome measures
Measure	ABP 938 n=273 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=136 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=134 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Mean Change From Baseline in Central Subfield Thickness (CST) Week 4	-136.5 μm Standard Deviation 108.91	-143.1 μm Standard Deviation 107.32	-149.7 μm Standard Deviation 107.01	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 8	-145.9 μm Standard Deviation 106.24	-146.3 μm Standard Deviation 110.39	-167.4 μm Standard Deviation 118.52	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 16	-125.2 μm Standard Deviation 124.81	-127.3 μm Standard Deviation 103.35	-143.2 μm Standard Deviation 121.93	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 24	-130.8 μm Standard Deviation 125.63	-131.7 μm Standard Deviation 102.98	-151.2 μm Standard Deviation 118.21	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 32	-133.2 μm Standard Deviation 122.93	-134.1 μm Standard Deviation 116.02	-154.8 μm Standard Deviation 114.22	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 40	-132.3 μm Standard Deviation 113.25	-135.6 μm Standard Deviation 119.07	-155.7 μm Standard Deviation 119.95	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 48	-132.3 μm Standard Deviation 124.15	-141.1 μm Standard Deviation 112.29	-157.8 μm Standard Deviation 121.23	—	—
Mean Change From Baseline in Central Subfield Thickness (CST) Week 52	-157.1 μm Standard Deviation 114.25	-159.1 μm Standard Deviation 108.82	-177.4 μm Standard Deviation 122.22	—	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Analysis Set: Consisted of all participants who received at least 1 dose of investigational product, with treatment assignment based on actual treatment received. TEAEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.

An adverse event (AE) is any untoward medical occurrence in a clinical trial participant. TEAEs were defined as those AEs that begin or increase in severity or frequency at or after the time of first treatment to the End of Study visit. Events of interest (EOIs) pre-specified for this study included endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events. Serious AEs were defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: * Results in death * Life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event.

Outcome measures

Outcome measures
Measure	ABP 938 n=288 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=288 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=273 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 n=133 Participants Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept n=136 Participants Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAEs	113 Participants	107 Participants	144 Participants	76 Participants	72 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any EOIs	6 Participants	3 Participants	9 Participants	8 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any Serious TEAEs	6 Participants	9 Participants	22 Participants	14 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Safety Analysis Set (Re-randomized and Treated): Consisted of all participants who received at least 1 dose of investigational product, with treatment assignment based on actual treatment received. Analysis included participants with available data at Baseline and at each timepoint.

Number of participants with positive post-baseline ADA result through Week 16 and post Week 16 with negative or no result at Baseline is reported.

Outcome measures

Outcome measures
Measure	ABP 938 n=288 Participants Participants were randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and remained on ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept n=288 Participants Participants were randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) and were re-randomized to receive aflibercept or ABP 938 dosing every 8 weeks from Week 16 until Week 48.	Aflibercept / ABP 938 n=273 Participants Participants who were initially randomized to receive 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8) were re-randomized to receive 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 n=133 Participants Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept n=136 Participants Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Number of Participants Developing Binding Antidrug Antibodies (ADAs)	1 Participants	4 Participants	4 Participants	3 Participants	0 Participants

Adverse Events

Through Week 16: ABP 938

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

Through Week 16: Aflibercept

Serious events: 9 serious events

Other events: 15 other events

Deaths: 2 deaths

Post Week 16: ABP 938 / ABP 938

Serious events: 22 serious events

Other events: 20 other events

Deaths: 2 deaths

Post Week 16: Aflibercept / ABP 938

Serious events: 14 serious events

Other events: 17 other events

Deaths: 2 deaths

Post Week 16: Aflibercept / Aflibercept

Serious events: 11 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Through Week 16: ABP 938 n=288 participants at risk Participants were treated with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).	Through Week 16: Aflibercept n=288 participants at risk Participants were treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).	Post Week 16: ABP 938 / ABP 938 n=273 participants at risk Participants who were initially treated with ABP 938 and remained on treatment with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 n=133 participants at risk Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept n=136 participants at risk Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Cardiac disorders Acute myocardial infarction	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Cardiac disorders Atrial fibrillation	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Cardiac disorders Cardiac failure congestive	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Cardiac disorders Ventricular tachycardia	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Endocrine disorders Adrenal haematoma	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Eye disorders Retinal detachment	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Eye disorders Retinal haemorrhage	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Eye disorders Visual acuity reduced	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Eye disorders Visual impairment	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Hepatobiliary disorders Cholangitis acute	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Infections and infestations Appendicitis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Infections and infestations Arthropod-borne disease	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Infections and infestations COVID-19	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.69% 2/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.73% 2/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Infections and infestations Diverticulitis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Infections and infestations Pneumonia	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Infections and infestations Urinary tract infection	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Contusion	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Fall	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.73% 2/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Femur fracture	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	1.1% 3/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Radius fracture	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Investigations Heart rate decreased	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Metabolism and nutrition disorders Dehydration	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rosai-Dorfman syndrome	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.75% 1/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Nervous system disorders Cerebrovascular accident	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.73% 2/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	2.3% 3/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Nervous system disorders Sciatica	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Nervous system disorders Syncope	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Renal and urinary disorders Bladder neck obstruction	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Renal and urinary disorders Haematuria	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Renal and urinary disorders Renal failure	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.74% 1/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.37% 1/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Vascular disorders Peripheral artery stenosis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Vascular disorders Subclavian artery stenosis	0.00% 0/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.35% 1/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	0.00% 0/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.

Other adverse events

Other adverse events
Measure	Through Week 16: ABP 938 n=288 participants at risk Participants were treated with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).	Through Week 16: Aflibercept n=288 participants at risk Participants were treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 4 weeks for the first 3 doses (i.e., Baseline/Day 1, Week 4, and Week 8).	Post Week 16: ABP 938 / ABP 938 n=273 participants at risk Participants who were initially treated with ABP 938 and remained on treatment with 2 mg (0.05 mL) of ABP 938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / ABP 938 n=133 participants at risk Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of ABP-938 by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.	Post Week 16: Aflibercept / Aflibercept n=136 participants at risk Participants who were initially treated with aflibercept and were re-randomized and treated with 2 mg (0.05 mL) of aflibercept by IVT injection in the study eye every 8 weeks from Week 16 until Week 48.
Eye disorders Conjunctival haemorrhage	4.2% 12/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	3.8% 11/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	1.5% 4/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	6.0% 8/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	5.9% 8/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.
Eye disorders Neovascular age-related macular degeneration	2.1% 6/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	1.4% 4/288 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	5.9% 16/273 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	7.5% 10/133 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.	8.1% 11/136 • Up to Week 52 All-cause mortality was collected for all participants enrolled/randomized in the study. Serious AEs and other AEs were collected for all participants who received at least one dose of study drug through Week 16. Serious AEs and other AEs were collected for all participants who were re-randomized and received at least one dose of study drug post Week 16.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER