Trial Outcomes & Findings for A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT03466411)

Last Updated: 2025-12-22

Results Overview

The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

1409 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2025-12-22

Participant Flow

This study consisted of 3 separate studies: Phase 2 dose-ranging study (GALAXI 1) and 2 identical Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). Participants with moderately to severely active Crohn's disease were enrolled in these studies.

Results were presented through Week 48 with a data cutoff date of 20 August 2020 (GALAXI 1), 20 October 2023 (GALAXI 2) and 16 October 2023 (GALAXI 3). At Week 48, participants who continued to benefit from treatment entered long-term extension period and continued to receive maintenance dose up to Week 236 which is still ongoing. Results of remaining duration of the study will be reported after study completion.

Participant milestones

Participant milestones
Measure	GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 1200 milligrams (mg) intravenous (IV) infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg subcutaneous (SC) injection every 4 weeks (q4w) as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection every 8 weeks (q8w) as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w Participants received a single weight-based dose of ustekinumab 6 milligrams per kilogram (mg/kg) IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for clinical response (CR) (decrease from baseline in Crohn's Disease Activity Index \[CDAI\] score of greater than or equal to \[\>=\] 100 points or CDAI score less than \[\<\] 150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.
Overall Study STARTED	77	151	148	150	76	73	73	73	71	70	148	149	150
Overall Study Participants Who Did Not Achieve CR at Week 12 and Crossed Over to Ustekinumab	49	0	0	0	51	0	0	0	0	43	0	0	0
Overall Study COMPLETED	71	138	131	137	69	58	64	64	66	62	145	141	140
Overall Study NOT COMPLETED	6	13	17	13	7	15	9	9	5	8	3	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 1200 milligrams (mg) intravenous (IV) infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg subcutaneous (SC) injection every 4 weeks (q4w) as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection every 8 weeks (q8w) as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w Participants received a single weight-based dose of ustekinumab 6 milligrams per kilogram (mg/kg) IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for clinical response (CR) (decrease from baseline in Crohn's Disease Activity Index \[CDAI\] score of greater than or equal to \[\>=\] 100 points or CDAI score less than \[\<\] 150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.
Overall Study Randomized but not Treated	0	0	0	0	0	0	0	0	0	0	0	1	0
Overall Study Lost to Follow-up	0	1	1	1	0	0	1	1	0	0	0	1	1
Overall Study Withdrawal by Subject	6	11	14	12	7	14	7	8	4	6	3	6	9
Overall Study Other	0	1	2	0	0	1	1	0	1	2	0	0	0

Baseline Characteristics

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=76 Participants Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	Total n=1408 Participants Total of all reporting groups	GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w n=151 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=148 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=150 Participants Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=73 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=73 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=73 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=71 Participants Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w or Ustekinumab 6mg/kg IV Then 90mg SC q8w n=70 Participants Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.	GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w n=148 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=148 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=150 Participants Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=77 Participants Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44. Participants who did not achieve CR at Week 12 received weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 12 followed by 90 mg SC injection q8w as maintenance dose from Week 20 through Week 44.
Region of Enrollment Belarus	0 Participants n=16 Participants	10 Participants n=13 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	2 Participants n=18 Participants	1 Participants n=102 Participants	0 Participants n=30 Participants	3 Participants n=37 Participants	2 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=16 Participants	1352 Participants n=13 Participants	143 Participants n=14 Participants	146 Participants n=14 Participants	143 Participants n=15 Participants	68 Participants n=18 Participants	66 Participants n=102 Participants	69 Participants n=30 Participants	69 Participants n=37 Participants	68 Participants n=127 Participants	142 Participants n=77 Participants	144 Participants n=37 Participants	143 Participants n=35 Participants	76 Participants n=15 Participants
Age, Categorical >=65 years	1 Participants n=16 Participants	56 Participants n=13 Participants	8 Participants n=14 Participants	2 Participants n=14 Participants	7 Participants n=15 Participants	5 Participants n=18 Participants	7 Participants n=102 Participants	4 Participants n=30 Participants	2 Participants n=37 Participants	2 Participants n=127 Participants	6 Participants n=77 Participants	4 Participants n=37 Participants	7 Participants n=35 Participants	1 Participants n=15 Participants
Age, Continuous	35.8 Years STANDARD_DEVIATION 12.48 • n=16 Participants	37.2 Years STANDARD_DEVIATION 13.14 • n=13 Participants	37.6 Years STANDARD_DEVIATION 13.4 • n=14 Participants	34.8 Years STANDARD_DEVIATION 11.48 • n=14 Participants	37.9 Years STANDARD_DEVIATION 13.61 • n=15 Participants	40.2 Years STANDARD_DEVIATION 14.28 • n=18 Participants	39.3 Years STANDARD_DEVIATION 15.51 • n=102 Participants	41.5 Years STANDARD_DEVIATION 14.41 • n=30 Participants	36.3 Years STANDARD_DEVIATION 12.08 • n=37 Participants	39 Years STANDARD_DEVIATION 12.79 • n=127 Participants	36.2 Years STANDARD_DEVIATION 13.03 • n=77 Participants	37.3 Years STANDARD_DEVIATION 12.86 • n=37 Participants	37 Years STANDARD_DEVIATION 12.76 • n=35 Participants	34.1 Years STANDARD_DEVIATION 11.81 • n=15 Participants
Sex: Female, Male Female	26 Participants n=16 Participants	586 Participants n=13 Participants	59 Participants n=14 Participants	60 Participants n=14 Participants	66 Participants n=15 Participants	35 Participants n=18 Participants	29 Participants n=102 Participants	27 Participants n=30 Participants	26 Participants n=37 Participants	26 Participants n=127 Participants	59 Participants n=77 Participants	76 Participants n=37 Participants	62 Participants n=35 Participants	35 Participants n=15 Participants
Sex: Female, Male Male	50 Participants n=16 Participants	822 Participants n=13 Participants	92 Participants n=14 Participants	88 Participants n=14 Participants	84 Participants n=15 Participants	38 Participants n=18 Participants	44 Participants n=102 Participants	46 Participants n=30 Participants	45 Participants n=37 Participants	44 Participants n=127 Participants	89 Participants n=77 Participants	72 Participants n=37 Participants	88 Participants n=35 Participants	42 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=16 Participants	65 Participants n=13 Participants	5 Participants n=14 Participants	7 Participants n=14 Participants	11 Participants n=15 Participants	3 Participants n=18 Participants	5 Participants n=102 Participants	4 Participants n=30 Participants	0 Participants n=37 Participants	4 Participants n=127 Participants	8 Participants n=77 Participants	5 Participants n=37 Participants	7 Participants n=35 Participants	2 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=16 Participants	1295 Participants n=13 Participants	142 Participants n=14 Participants	136 Participants n=14 Participants	131 Participants n=15 Participants	69 Participants n=18 Participants	64 Participants n=102 Participants	66 Participants n=30 Participants	69 Participants n=37 Participants	64 Participants n=127 Participants	136 Participants n=77 Participants	139 Participants n=37 Participants	137 Participants n=35 Participants	71 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=16 Participants	48 Participants n=13 Participants	4 Participants n=14 Participants	5 Participants n=14 Participants	8 Participants n=15 Participants	1 Participants n=18 Participants	4 Participants n=102 Participants	3 Participants n=30 Participants	2 Participants n=37 Participants	2 Participants n=127 Participants	4 Participants n=77 Participants	4 Participants n=37 Participants	6 Participants n=35 Participants	4 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants	2 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	2 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	19 Participants n=16 Participants	257 Participants n=13 Participants	28 Participants n=14 Participants	38 Participants n=14 Participants	23 Participants n=15 Participants	6 Participants n=18 Participants	10 Participants n=102 Participants	9 Participants n=30 Participants	8 Participants n=37 Participants	5 Participants n=127 Participants	28 Participants n=77 Participants	34 Participants n=37 Participants	32 Participants n=35 Participants	17 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=16 Participants	11 Participants n=13 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	3 Participants n=18 Participants	0 Participants n=102 Participants	1 Participants n=30 Participants	1 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	2 Participants n=15 Participants
Race (NIH/OMB) Black or African American	3 Participants n=16 Participants	23 Participants n=13 Participants	1 Participants n=14 Participants	0 Participants n=14 Participants	4 Participants n=15 Participants	2 Participants n=18 Participants	2 Participants n=102 Participants	0 Participants n=30 Participants	1 Participants n=37 Participants	3 Participants n=127 Participants	1 Participants n=77 Participants	3 Participants n=37 Participants	3 Participants n=35 Participants	0 Participants n=15 Participants
Race (NIH/OMB) White	50 Participants n=16 Participants	1080 Participants n=13 Participants	118 Participants n=14 Participants	107 Participants n=14 Participants	116 Participants n=15 Participants	61 Participants n=18 Participants	59 Participants n=102 Participants	58 Participants n=30 Participants	61 Participants n=37 Participants	58 Participants n=127 Participants	117 Participants n=77 Participants	108 Participants n=37 Participants	111 Participants n=35 Participants	56 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=16 Participants	35 Participants n=13 Participants	4 Participants n=14 Participants	2 Participants n=14 Participants	6 Participants n=15 Participants	1 Participants n=18 Participants	2 Participants n=102 Participants	3 Participants n=30 Participants	0 Participants n=37 Participants	4 Participants n=127 Participants	2 Participants n=77 Participants	3 Participants n=37 Participants	4 Participants n=35 Participants	2 Participants n=15 Participants
Region of Enrollment Australia	1 Participants n=16 Participants	22 Participants n=13 Participants	2 Participants n=14 Participants	1 Participants n=14 Participants	3 Participants n=15 Participants	1 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	5 Participants n=77 Participants	2 Participants n=37 Participants	6 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Austria	0 Participants n=16 Participants	3 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	1 Participants n=18 Participants	0 Participants n=102 Participants	1 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Belgium	0 Participants n=16 Participants	5 Participants n=13 Participants	1 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	1 Participants n=127 Participants	0 Participants n=77 Participants	1 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Bosnia and Herzegovina	0 Participants n=16 Participants	14 Participants n=13 Participants	0 Participants n=14 Participants	2 Participants n=14 Participants	2 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	0 Participants n=30 Participants	1 Participants n=37 Participants	0 Participants n=127 Participants	2 Participants n=77 Participants	1 Participants n=37 Participants	3 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Brazil	3 Participants n=16 Participants	53 Participants n=13 Participants	8 Participants n=14 Participants	6 Participants n=14 Participants	12 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	6 Participants n=77 Participants	7 Participants n=37 Participants	9 Participants n=35 Participants	2 Participants n=15 Participants
Region of Enrollment Canada	2 Participants n=16 Participants	27 Participants n=13 Participants	2 Participants n=14 Participants	4 Participants n=14 Participants	5 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	2 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	6 Participants n=37 Participants	4 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment China	12 Participants n=16 Participants	120 Participants n=13 Participants	15 Participants n=14 Participants	22 Participants n=14 Participants	12 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	18 Participants n=77 Participants	19 Participants n=37 Participants	10 Participants n=35 Participants	12 Participants n=15 Participants
Region of Enrollment Colombia	0 Participants n=16 Participants	1 Participants n=13 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Croatia	0 Participants n=16 Participants	4 Participants n=13 Participants	2 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=15 Participants	0 Participants n=18 Participants	1 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Czech Republic	1 Participants n=16 Participants	16 Participants n=13 Participants	1 Participants n=14 Participants	4 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	1 Participants n=30 Participants	1 Participants n=37 Participants	0 Participants n=127 Participants	2 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	3 Participants n=15 Participants
Region of Enrollment France	1 Participants n=16 Participants	30 Participants n=13 Participants	1 Participants n=14 Participants	1 Participants n=14 Participants	2 Participants n=15 Participants	2 Participants n=18 Participants	2 Participants n=102 Participants	6 Participants n=30 Participants	1 Participants n=37 Participants	2 Participants n=127 Participants	4 Participants n=77 Participants	2 Participants n=37 Participants	4 Participants n=35 Participants	2 Participants n=15 Participants
Region of Enrollment Georgia	0 Participants n=16 Participants	10 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	3 Participants n=102 Participants	1 Participants n=30 Participants	1 Participants n=37 Participants	1 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	1 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Germany	1 Participants n=16 Participants	27 Participants n=13 Participants	4 Participants n=14 Participants	2 Participants n=14 Participants	1 Participants n=15 Participants	3 Participants n=18 Participants	4 Participants n=102 Participants	0 Participants n=30 Participants	2 Participants n=37 Participants	2 Participants n=127 Participants	2 Participants n=77 Participants	4 Participants n=37 Participants	2 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Greece	0 Participants n=16 Participants	1 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	1 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Hungary	1 Participants n=16 Participants	20 Participants n=13 Participants	4 Participants n=14 Participants	1 Participants n=14 Participants	4 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	4 Participants n=37 Participants	5 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment India	0 Participants n=16 Participants	10 Participants n=13 Participants	2 Participants n=14 Participants	2 Participants n=14 Participants	2 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	1 Participants n=37 Participants	2 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Israel	2 Participants n=16 Participants	26 Participants n=13 Participants	0 Participants n=14 Participants	9 Participants n=14 Participants	0 Participants n=15 Participants	2 Participants n=18 Participants	2 Participants n=102 Participants	2 Participants n=30 Participants	2 Participants n=37 Participants	0 Participants n=127 Participants	4 Participants n=77 Participants	1 Participants n=37 Participants	0 Participants n=35 Participants	2 Participants n=15 Participants
Region of Enrollment Italy	1 Participants n=16 Participants	15 Participants n=13 Participants	3 Participants n=14 Participants	1 Participants n=14 Participants	0 Participants n=15 Participants	2 Participants n=18 Participants	2 Participants n=102 Participants	2 Participants n=30 Participants	0 Participants n=37 Participants	1 Participants n=127 Participants	1 Participants n=77 Participants	0 Participants n=37 Participants	1 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Japan	4 Participants n=16 Participants	68 Participants n=13 Participants	9 Participants n=14 Participants	6 Participants n=14 Participants	4 Participants n=15 Participants	3 Participants n=18 Participants	5 Participants n=102 Participants	6 Participants n=30 Participants	4 Participants n=37 Participants	2 Participants n=127 Participants	4 Participants n=77 Participants	7 Participants n=37 Participants	13 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Jordan	1 Participants n=16 Participants	42 Participants n=13 Participants	9 Participants n=14 Participants	3 Participants n=14 Participants	9 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	0 Participants n=30 Participants	2 Participants n=37 Participants	1 Participants n=127 Participants	4 Participants n=77 Participants	3 Participants n=37 Participants	4 Participants n=35 Participants	4 Participants n=15 Participants
Region of Enrollment Latvia	0 Participants n=16 Participants	10 Participants n=13 Participants	1 Participants n=14 Participants	1 Participants n=14 Participants	0 Participants n=15 Participants	3 Participants n=18 Participants	1 Participants n=102 Participants	1 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	1 Participants n=37 Participants	1 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Lebanon	2 Participants n=16 Participants	19 Participants n=13 Participants	2 Participants n=14 Participants	3 Participants n=14 Participants	4 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	1 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	4 Participants n=37 Participants	1 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Lithuania	0 Participants n=16 Participants	3 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	2 Participants n=30 Participants	1 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Malaysia	1 Participants n=16 Participants	15 Participants n=13 Participants	0 Participants n=14 Participants	2 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	2 Participants n=102 Participants	0 Participants n=30 Participants	1 Participants n=37 Participants	0 Participants n=127 Participants	3 Participants n=77 Participants	1 Participants n=37 Participants	2 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Netherlands	0 Participants n=16 Participants	12 Participants n=13 Participants	4 Participants n=14 Participants	1 Participants n=14 Participants	2 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	1 Participants n=37 Participants	0 Participants n=35 Participants	4 Participants n=15 Participants
Region of Enrollment New Zealand	0 Participants n=16 Participants	12 Participants n=13 Participants	2 Participants n=14 Participants	1 Participants n=14 Participants	0 Participants n=15 Participants	1 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	4 Participants n=77 Participants	0 Participants n=37 Participants	3 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Poland	16 Participants n=16 Participants	292 Participants n=13 Participants	26 Participants n=14 Participants	32 Participants n=14 Participants	28 Participants n=15 Participants	11 Participants n=18 Participants	18 Participants n=102 Participants	15 Participants n=30 Participants	21 Participants n=37 Participants	25 Participants n=127 Participants	33 Participants n=77 Participants	24 Participants n=37 Participants	33 Participants n=35 Participants	10 Participants n=15 Participants
Region of Enrollment Portugal	0 Participants n=16 Participants	4 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	1 Participants n=37 Participants	1 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Macedonia	1 Participants n=16 Participants	9 Participants n=13 Participants	1 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	1 Participants n=77 Participants	1 Participants n=37 Participants	1 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Russian Federation	8 Participants n=16 Participants	115 Participants n=13 Participants	13 Participants n=14 Participants	9 Participants n=14 Participants	9 Participants n=15 Participants	6 Participants n=18 Participants	3 Participants n=102 Participants	8 Participants n=30 Participants	4 Participants n=37 Participants	3 Participants n=127 Participants	14 Participants n=77 Participants	14 Participants n=37 Participants	14 Participants n=35 Participants	10 Participants n=15 Participants
Region of Enrollment Saudi Arabia	0 Participants n=16 Participants	2 Participants n=13 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	1 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Slovakia	0 Participants n=16 Participants	17 Participants n=13 Participants	3 Participants n=14 Participants	2 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	0 Participants n=30 Participants	2 Participants n=37 Participants	2 Participants n=127 Participants	1 Participants n=77 Participants	3 Participants n=37 Participants	1 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Korea, South	2 Participants n=16 Participants	32 Participants n=13 Participants	2 Participants n=14 Participants	3 Participants n=14 Participants	3 Participants n=15 Participants	1 Participants n=18 Participants	2 Participants n=102 Participants	1 Participants n=30 Participants	3 Participants n=37 Participants	2 Participants n=127 Participants	2 Participants n=77 Participants	5 Participants n=37 Participants	4 Participants n=35 Participants	2 Participants n=15 Participants
Region of Enrollment Spain	0 Participants n=16 Participants	12 Participants n=13 Participants	1 Participants n=14 Participants	0 Participants n=14 Participants	3 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	1 Participants n=30 Participants	0 Participants n=37 Participants	1 Participants n=127 Participants	1 Participants n=77 Participants	0 Participants n=37 Participants	2 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Serbia	6 Participants n=16 Participants	64 Participants n=13 Participants	5 Participants n=14 Participants	2 Participants n=14 Participants	8 Participants n=15 Participants	2 Participants n=18 Participants	3 Participants n=102 Participants	3 Participants n=30 Participants	6 Participants n=37 Participants	2 Participants n=127 Participants	8 Participants n=77 Participants	9 Participants n=37 Participants	7 Participants n=35 Participants	3 Participants n=15 Participants
Region of Enrollment Taiwan	0 Participants n=16 Participants	7 Participants n=13 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	1 Participants n=30 Participants	0 Participants n=37 Participants	1 Participants n=127 Participants	1 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Tunisia	1 Participants n=16 Participants	19 Participants n=13 Participants	5 Participants n=14 Participants	2 Participants n=14 Participants	1 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	3 Participants n=77 Participants	5 Participants n=37 Participants	1 Participants n=35 Participants	1 Participants n=15 Participants
Region of Enrollment Turkey	0 Participants n=16 Participants	10 Participants n=13 Participants	0 Participants n=14 Participants	1 Participants n=14 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants	1 Participants n=102 Participants	0 Participants n=30 Participants	2 Participants n=37 Participants	1 Participants n=127 Participants	1 Participants n=77 Participants	2 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment Ukraine	4 Participants n=16 Participants	106 Participants n=13 Participants	11 Participants n=14 Participants	10 Participants n=14 Participants	7 Participants n=15 Participants	9 Participants n=18 Participants	7 Participants n=102 Participants	7 Participants n=30 Participants	7 Participants n=37 Participants	6 Participants n=127 Participants	11 Participants n=77 Participants	12 Participants n=37 Participants	7 Participants n=35 Participants	8 Participants n=15 Participants
Region of Enrollment United Kingdom	0 Participants n=16 Participants	5 Participants n=13 Participants	2 Participants n=14 Participants	0 Participants n=14 Participants	3 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants	0 Participants n=37 Participants	0 Participants n=127 Participants	0 Participants n=77 Participants	0 Participants n=37 Participants	0 Participants n=35 Participants	0 Participants n=15 Participants
Region of Enrollment United States	5 Participants n=16 Participants	119 Participants n=13 Participants	10 Participants n=14 Participants	9 Participants n=14 Participants	15 Participants n=15 Participants	14 Participants n=18 Participants	10 Participants n=102 Participants	13 Participants n=30 Participants	6 Participants n=37 Participants	14 Participants n=127 Participants	7 Participants n=77 Participants	6 Participants n=37 Participants	8 Participants n=35 Participants	2 Participants n=15 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: The primary efficacy analysis set consisted of randomized participants who received at least 1 dose of study intervention (including a partial dose), except for those participants whose induction dosing was discontinued as a result of the urgent safety measure. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. This outcome measure was planned to be collected and analyzed for specified arms only.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=58 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=62 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=60 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w n=60 Participants Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12	-143.7 Units on a scale Standard Deviation 96.58	-139.2 Units on a scale Standard Deviation 100.71	-159.8 Units on a scale Standard Deviation 110.52	-34.4 Units on a scale Standard Deviation 104.85

PRIMARY outcome

Timeframe: Weeks 48

Population: The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the simple endoscopic score for crohn's disease (SES-CD) eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (\>=) 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=146 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=143 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=76 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48	54.8 Percentage of participants	49.0 Percentage of participants	11.8 Percentage of participants	—

PRIMARY outcome

Timeframe: Weeks 48

Population: The primary analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data were planned to be collected and analyzed for specified arms only.

CR: decrease from BL in CDAI score \>=100/\<150. ER: \>=50% improvement from BL in SES-CD score/SES-CD score \<=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=146 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=143 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=76 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48	38.4 Percentage of participants	39.2 Percentage of participants	5.3 Percentage of participants	—

PRIMARY outcome

Timeframe: Weeks 48

Clinical response was defined as a decrease from baseline in CDAI score \>= 100 points or CDAI score \<150. Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=150 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=143 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=72 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48	48.0 Percentage of participants	46.9 Percentage of participants	12.5 Percentage of participants	—

PRIMARY outcome

Timeframe: Weeks 48

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=150 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=143 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=72 Participants Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48	36.0 Percentage of participants	33.6 Percentage of participants	5.6 Percentage of participants	—

PRIMARY outcome

Timeframe: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 2 Groups 1 and 2, and for participants who received placebo in GALAXI 2 Group 4.

Clinical remission was defined as a CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=76 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=289 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12	22.4 Percentage of participants	47.1 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Week 12

Endoscopic response was defined as \>=50% improvement from baseline in SES-CD score or SES-CD score \<=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=76 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=289 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12	10.5 Percentage of participants	37.7 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 3 Groups 1 and 2, and for participants who received placebo in GALAXI 3 Group 4.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=72 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=293 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12	15.3 Percentage of participants	47.1 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Week 12

Population: Primary analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention and satisfied the SES-CD eligibility criteria (that is, screening SES-CD score \>=6 \[or \>=4 for participants with isolated ileal disease\]). Data for this outcome measure was planned to be collected and analyzed as a combined group for participants who received guselkumab induction dose in GALAXI 3 Groups 1 and 2, and for participants who received placebo in GALAXI 3 Group 4.

Outcome measures

Outcome measures
Measure	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=72 Participants Participants received guselkumab 1200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=293 Participants Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w Participants received placebo (matching to guselkumab) IV infusion at Weeks 0, 4 and 8. At Week 12, participants were evaluated for CR (decrease from baseline in CDAI score of \>=100 points or CDAI score \<150). Participants who achieved CR at Week 12 continued to receive placebo q4w from Week 12 through Week 44.
Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12	13.9 Percentage of participants	36.2 Percentage of participants	—	—

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=148 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=150 participants at risk Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 2 (Group 4) Placebo q4w n=77 participants at risk Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.	GALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=49 participants at risk Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.	GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w n=151 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=148 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=150 participants at risk Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 3 (Group 4) Placebo q4w n=76 participants at risk Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.	GALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=51 participants at risk Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=73 participants at risk Participants received guselkumab 1200 milligrams (mg) intravenous (IV) infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg subcutaneous (SC) injection every 4 weeks (q4w) as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=73 participants at risk Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=73 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=71 participants at risk Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 1 (Group 5) Placebo q4w n=70 participants at risk Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.	GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=43 participants at risk Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.	GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w n=148 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.
Blood and lymphatic system disorders Anaemia	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Cardiac disorders Angina Unstable	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Cardiac disorders Coronary Artery Disease	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Abdominal Pain	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Anal Fistula	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 2/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Colitis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Crohn's Disease	3.4% 5/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 4/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.9% 6/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 2/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.2% 3/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Enterovesical Fistula	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Gastrointestinal Tract Irritation	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Haematochezia	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Ileal Stenosis	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Ileus	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Inflammatory Bowel Disease	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Intestinal Haemorrhage	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Intestinal Obstruction	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Intestinal Stenosis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Large Intestinal Stenosis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Large Intestine Polyp	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Small Intestinal Perforation	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Small Intestinal Stenosis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Subileus	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Vomiting	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
General disorders Non-Cardiac Chest Pain	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Hepatobiliary disorders Bile Duct Stone	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Hepatobiliary disorders Drug-Induced Liver Injury	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Hepatobiliary disorders Hepatitis Toxic	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Immune system disorders Anaphylactic Reaction	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Abdominal Abscess	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Abdominal Infection	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Abdominal Sepsis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Abscess Intestinal	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Abscess Limb	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Acute Sinusitis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Anal Abscess	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Bacterial Infection	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Bronchitis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Covid-19	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Covid-19 Pneumonia	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Device Related Bacteraemia	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Enterocolitis Infectious	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Epididymitis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Gastroenteritis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Gastroenteritis Viral	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Intestinal Fistula Infection	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Liver Abscess	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Pelvic Abscess	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Post Procedural Infection	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Postoperative Wound Infection	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Testicular Abscess	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Vascular Device Infection	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Procedural Intestinal Perforation	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Skin Laceration	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Skull Fracture	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Injury, poisoning and procedural complications Traumatic Haematoma	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Investigations Liver Function Test Increased	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Metabolism and nutrition disorders Calcium Deficiency	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Arthritis Enteropathic	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Desmoid Tumour	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular Thyroid Cancer	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Tract Adenoma	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Nervous system disorders Hyperaesthesia	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Nervous system disorders Ischaemic Stroke	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Nervous system disorders Lumbar Radiculopathy	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.66% 1/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Nervous system disorders Wernicke's Encephalopathy	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Psychiatric disorders Adjustment Disorder	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Psychiatric disorders Adjustment Disorder with Depressed Mood	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Psychiatric disorders Depression Suicidal	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Renal and urinary disorders Calculus Urinary	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Renal and urinary disorders Nephrolithiasis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Renal and urinary disorders Renal Colic	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Renal and urinary disorders Ureterolithiasis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Reproductive system and breast disorders Ovarian Cyst Ruptured	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Reproductive system and breast disorders Uterine Polyp	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Social circumstances Miscarriage of Partner	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Vascular disorders Deep Vein Thrombosis	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.

Other adverse events

Other adverse events
Measure	GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=148 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 2 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=150 participants at risk Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 2 (Group 4) Placebo q4w n=77 participants at risk Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.	GALAXI 2 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=49 participants at risk Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.	GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w n=151 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=148 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 3 (Group 3) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=150 participants at risk Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 3 (Group 4) Placebo q4w n=76 participants at risk Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.	GALAXI 3 (Group 4) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=51 participants at risk Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.	GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w n=73 participants at risk Participants received guselkumab 1200 milligrams (mg) intravenous (IV) infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg subcutaneous (SC) injection every 4 weeks (q4w) as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w n=73 participants at risk Participants received guselkumab 600 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.	GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w n=73 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 100 mg SC injection q8w as maintenance dose from Week 16 through Week 40.	GALAXI 1 (Group 4) Ustekinumab 6 mg/kg IV Followed by 90 mg SC q8w n=71 participants at risk Participants received a single weight-based dose of ustekinumab 6 mg/kg IV infusion as induction dose at Week 0. From Week 8, participants received ustekinumab 90 mg SC injection q8w as maintenance dose through Week 40.	GALAXI 1 (Group 5) Placebo q4w n=70 participants at risk Participants randomized to receive placebo IV infusion q4w, excluding data after participant crossed over to ustekinumab.	GALAXI 1 (Group 5) Placebo Followed by Ustekinumab 6 mg/kg IV Then 90 mg SC q8w n=43 participants at risk Participants randomized to receive placebo IV infusion q4w who crossed over to ustekinumab. Data in this group occurred after a participant crossed over to ustekinumab.	GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w n=148 participants at risk Participants received guselkumab 200 mg IV infusion as induction dose at Weeks 0, 4 and 8. Participants then received guselkumab 200 mg SC injection q4w as maintenance dose from Week 12 through Week 44.
Blood and lymphatic system disorders Anaemia	5.4% 8/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.3% 11/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.3% 5/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.7% 7/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.3% 5/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.6% 5/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.9% 3/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 3/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.2% 6/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.9% 7/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.7% 4/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.3% 1/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 10/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Abdominal Pain	7.4% 11/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.7% 13/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.3% 5/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.4% 8/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.0% 12/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.3% 4/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.0% 5/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.3% 3/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.1% 9/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Crohn's Disease	5.4% 8/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.0% 12/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	10.4% 8/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 2/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.3% 11/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 10/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.3% 11/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	10.5% 8/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.8% 4/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 5/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.2% 6/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	15.5% 11/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.7% 4/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	11.6% 5/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.1% 12/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Diarrhoea	4.1% 6/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.3% 11/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.8% 2/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.9% 2/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.4% 5/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Gastrointestinal disorders Nausea	3.4% 5/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.0% 6/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 4/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 4/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 4/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.9% 6/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 3/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.6% 4/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.9% 2/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.4% 5/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
General disorders Pyrexia	6.8% 10/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.3% 14/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.5% 5/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.3% 8/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.1% 9/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.0% 12/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.9% 3/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 3/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.2% 6/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.0% 5/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.9% 2/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.3% 1/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.4% 8/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Covid-19	12.2% 18/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	16.0% 24/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 2/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	14.3% 7/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	20.5% 31/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	18.2% 27/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	10.7% 16/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	10.5% 8/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.8% 5/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	14.9% 22/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Nasopharyngitis	4.7% 7/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.0% 12/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 2/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.3% 11/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.4% 5/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.7% 7/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 2/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	11.0% 8/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	12.3% 9/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	11.0% 8/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	11.3% 8/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.3% 3/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.3% 4/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 10/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Infections and infestations Upper Respiratory Tract Infection	10.1% 15/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.7% 10/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 2/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.6% 13/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.5% 14/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.7% 13/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.8% 5/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.2% 6/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.9% 7/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.6% 6/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.7% 2/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.1% 12/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Investigations Alanine Aminotransferase Increased	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.3% 5/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 5/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.3% 1/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 2/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Investigations Haemoglobin Decreased	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.67% 1/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 2/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.68% 1/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 2/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 3/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.7% 2/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.1% 5/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 14/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.0% 12/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.2% 4/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.1% 3/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.3% 11/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.1% 9/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.3% 8/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 2/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	11.0% 8/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.0% 5/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.7% 4/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	7.0% 3/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.5% 14/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Musculoskeletal and connective tissue disorders Back Pain	3.4% 5/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 2/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.6% 4/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 3/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.3% 1/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.5% 4/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 5/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 3/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.8% 2/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.3% 1/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.1% 6/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.
Nervous system disorders Headache	4.1% 6/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.7% 13/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	3.9% 3/77 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	2.0% 1/49 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.3% 8/151 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.1% 9/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	4.0% 6/150 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	5.3% 4/76 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	0.00% 0/51 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.6% 7/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	13.7% 10/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	6.8% 5/73 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	8.5% 6/71 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	1.4% 1/70 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	9.3% 4/43 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.	10.8% 16/148 • From Week 0 up to Week 48 All Cause Mortality: All randomized participants. Serious adverse event (AE)/Other AEs: GALAXI 1: Safety analysis set: all participants who were randomized and received at least 1 dose of study intervention (including partial dose); GALAXI 2 and 3: All treated safety analysis set: all randomized participants who received at least 1 (partial or complete) dose of study intervention. GALAXI 1: MedDRA version (v)23.0, GALAXI 2 \& 3:MedDRA v26.0. As planned, safety data was analyzed per intervention.

Additional Information

Senior Medical Leader PEDIATRICS IMM

J&J Innovative Medicine

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER